Our Family’s CSID Evolution – 2019 Update

It’s interesting how this blog has evolved over the years. Since by whatever combination of methods and miracles, my youngest child with CSID is pretty much able to eat whatever eat wants within reason (often at my disapproval – but how many of you parents would deny your children waffles and peanut butter if they could tolerate them after years of extreme diet limitations?!)

Both of my CSID offspring have learned their limits, and occasionally over do it. But they recover quickly and go on living normal lives for the most part.

I’m going to be honest here for a couple of reasons.

  1. I don’t want to give some false sense that we all make perfect dietary choices or that our refrigerator and pantry are somehow void of packaged or processed food. In an ideal world, I wish it was! But that’s not realistic and I’ve had to learn to choose my battles and focus on those of us who require the most specified dietary needs at the present time.
  2. I want to give hope to those struggles, whether for themselves or on behalf of their children. There were many years when I did have to spend hours in the kitchen each day, carefully monitoring every bit of food Parker ingested. (Eczema and Food Allergies ) For two years of that time, I was also working full time! Every extra dollar we had went to supplements and specialty ingredients. I don’t deny his “healing” process started with prayer, but that doesn’t mean God didn’t direct me on how to care for him so I could share my experience here, in a public and global platform, and that my methods could also bring relief and success to others.

My CSID children’s tolerance update 2019

Parker, age 14

Parker will experience digestive complaints when he over does starches (such as the week he ate several McDonald s breakfast sandwiches). Though I’m more convinced the oils used to cook fast food also irritates his digestion, since he can eat similar food at home without issue. When he does experience digestion upset, he takes my home tummy remedy of peppermint tea, lemon, honey, and about 1/2 teaspoon marshmallow root powder. Generally after a BM, he’s back to normal!

Within the last year, Parker has also been assessed for learning issues. He’s struggled with school as far as attention, turning in work, keeping track of assignments, etc. When he got a concussion in September of 2017, these problems got much worse and his doctor referred him to a specialist who conducted a variety of tests. The conclusion is that he has ADHD combined type. I’m not 100% convinced that his increasing his carbohydrates intake of typical American foods isn’t making the symptoms worse, but he’s almost fifteen years old now.

He doesn’t have a lot of time to experiment with diet changes and see if that helps. He was prescribed medication, but I’m not quite on board with that yet. One side-effect is reduced appetite and since he’s still not gaining and keeping on weight consistently, I’m not sure that would be a good idea. Not to mention the other slew of long-term effects on his brain.  For now, he’s got a 504 plan. I mention this in case other children, teens, or adults with CSID also have ADHD or learning issues. Maybe doctors will take the brain-gut connection more seriously if these connections are mentioned more often.

Elora, age 25

My daughter, Elora, with CSID is now a 25 year old mother ready to give birth to her second baby in a matter of weeks. She mostly avoids juices and any drink containing sugar, including apple juice and soda pop containing corn syrup or cane sugar. She uses fructose in her coffee, however. She also knows she can only take a couple of bites of cake! More than that, and she’s running to the restroom.

I don’t hear of any other digestive complaints from her aside from irregularity. But she is 9 months pregnant! Also a reminder that with her first pregnancy, she felt her tolerance to sugar increased for whatever reason. However, it declined again after she quit breastfeeding. Not sure the connection to CSID here, but again, I mention details in the case anyone else out there has a similar experience.

I’m super excited about gaining a granddaughter! And will obviously be distracted even more than normal once she arrives!


My Son with Celiac Update

Dawson, age 19

Back in August, I took my son, Dawson, to a dietitian I met at a networking meeting I go to every week for our hardwood flooring business. Her and her husband, a chiropractor, run a Apex Chiropractic and Wellness in Boise, Idaho.

Aside from gluten intolerance, Dawson has suffered from ADHD, social anxiety, mild depression, insomnia, and chronic ankle issues for several years. He also gets hives or headaches for unknown reasons.

So Erin recommended a blood test that would determine which foods, chemicals, etc. could be causing inflammation in his body, followed by a protocol of  14-day menu plans that started with eliminating anything that was causing the slightest amount of inflammation.

If you have the resources to do so and can get a dietitian or physician to order the test, I strongly recommend you do so! It may help you to discover the mystery component that is contributing to ongoing symptoms regardless of your attempts to curb major dietary culprits.

MEDIATOR RELEASE TEST and LEAP REPORT

The test is named MRT (Mediator Release Test) and it was done by Oxford Biomedical Technologies in Riviera Beach, FL. The results were included in a report and protocol called LEAP ImmunoCalm (R) Dietary Management Program. My son had his blood done at a local lab and they mailed it in. I imagine any dietetic or physician can have it ordered. I’ve linked the test and program to their names above to the lab website that conducted the tests.

The results were a bit of a blow. Since I’m summarizing here, I won’t go into details, but they did reveal he was still getting traces of wheat somehow, and that he is having major inflammation response to corn, rice, soy, chicken, and turkey! Other foods causing slight, yet significant inflammation are sugar, onion, tomato, dairy, black pepper, and vanilla. You see how the most random food can be revealed?!

Dawson is doing better as of today, but still working on learning how to prepare his meals, gaining weights, and eating often enough to maintain his energy levels. He has not added the major inflammatory foods back into his diet as of yet.

Of course, this has made it very challenging in our house as I am also avoiding very specific foods in order to get back on track with a Paleo-base diet by starting with another 21-day sugar detox, then transitioning into Keto for however long it takes for me to maintain self-control and indefinitely avoid processed sugar, gluten and most grains.

More on that in my next post, coming soon!

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My 4th 21-Day Sugar Detox – 2019

As I geared up for my daughter, Tayler’s, wedding this past September, I knew I needed to be at my best, so I took on my third 21-day sugar detox. Every time I’ve done this, I’ve learned something new about how to simplify the process as well as how my body and mind respond to sugar (this includes all forms natural or processed such as fruit, honey, etc.) and grain-based carbohydrates such as rice or corn.

From my past two 21-day sugar detox experiences, the first few days were always the most difficult. But once I was sleeping better and had more energy, it was much easier to avoid temptation of taboo foods for the remaining of the detox or fasting period.

However, I always seem to start giving in once the holidays begin. It starts with indulging on a few pieces of Halloween candy and then evolves into a full meal at Carl’s Jr during a long day of Christmas shopping! By the time it’s actually December, I’m roughly eating 50/50 Paleo/SAD (Standard American Diet). I’m sleeping less, more irritable, and the brain-fog and forgetting things is out of control. And the end of 2018 was no exception.

I honestly don’t know how long I will succeed this time, but I’ve got to give it another try. I know I will feel better inside and out — for however long it lasts!


Past 21 Day Sugar Detox Challenges

As I prepared for my fourth 21-day-sugar detox, I reflected on some things that have made it challenging in the past. I’m really working on being realistic with my goals for 2019, so I needed to asses the struggles I’d had before, and perhaps pinpoint why I’ve found it hard to stick with the diet for the long-term.

Eating Often Enough

On any given week day, I tend to consume 2 to 3 cups of coffee over a couple of hours as I review my goals for the day and get to work. Our family business requires a lot of tasks and some days I get caught up in bookkeeping or project scheduling and before I know it, it’s 2pm and I haven’t eaten a thing!

Then I’m off to prepare a batch of Paleo pancakes with eggs (no matter the time of day, I usually prefer a breakfast food first!)

My second meal of the day is then dinner at around 7pm. This will include a large portion of animal-based protein, cooked vegetables and a starch (rice, corn, potatoes, or sweet potatoes).

I don’t drink enough water throughout the day either.

So my first hurdle to overcome is getting used to eating three meals with snacks in between to avoid getting hungry, which during the detox leads me to getting hangry!

Meal Planning Challenges

I’ve been known to get pretty ambitious once I decide to take on major dietary changes. I’m determined to follow the diet exactly and go head-long into ordering and shopping to stock my pantry and fridge with all the necessary items for a full week or more of recipes.

Then I end up with way too much fresh food on hand, and find myself scrambling to prepare all of it regardless of the recipes and menu. I have too many left overs or lack the time to use all the fresh produce, and inevitably end up throwing stuff out.

As of today, I’m on DAY 5, but started out using the food already in my fridge for the first few days. I had deli meat and cheese, eggs, salad ingredients and some fresh vegetables I needed to use up first.

I finally went shopping based on the Week 1 menu in the 21 Day Sugar Detox Daily guide on Friday and ordered the few pantry items from Thrive Market that I knew I couldn’t find at Whole Foods.

Online Updating

My other challenge in the past was planning on updating my progress regularly and failing to keep consistent. As part of my overall 2019 goals, I want to be realistic about the rate I post to my various social media outlets. (I posted to my Author Website last week on this if you’d like to read more click HERE)

For this blog/website, the most realistic effort I can make at this point is to tag my relevant Instagram (find me at rk3775)  posts with #csidrecipes #ketoforkids #21daysugardetox #paleo and other similar phrasing. Before I take on trying to add more posts, I really need to review and update all the current posts that are already here and note the date of the update for those who haven’t been following this blog for long.


Recommended Resources for CSID, Paleo, Sugar Detox and Keto

As always, I highly recommend the following recipe books and dietary guides, as both Diane Sanfilippo and Danielle Walker have become my go-to gals when it comes to amazing recipes and paleo/keto lifestyle education.

As always, please modify any recipe per your specific dietary needs and food sensitivities!

Diane Sanfillippo (BalancedBites)

PRACTICAL PALEO

21 DAY SUGAR DETOX DAILY GUIDE

KETO QUICK START


Danielle Walker (AgainstAllGrain)

Find the link to all these books HERE

  • Against All Grain
  • Against All Grain: Meals Made Simple
  • Celebrations
  • Eat What You Love

 

I pray peace and hope in 2019 to you all! Have an amazing year!

CSID Moms Wanted to Help Me Update My CSID Recipes Blog

I woke up this morning with a conversation thread from a CSID Parents & Patients group on Facebook feed. I spent about a half hour reading through recent posts and am still amazed at how little information is out there to help parents and newly diagnosed adults. Though I’ve said this again and again — I’m still learning nearly 12 years after my youngest child was diagnosed!

Yet, I feel my experience and all I’ve learned can help others, if nothing else, realize they are not alone. Though I’ve never been able to talk a GI into doing a repeated bowel biopsy, I believe our tolerance to certain amounts of sucrose and starch increase as we monitor our diets and reduce excess amounts of irritating foods.

As much as I want to continue to document our experiences and new recipes, the honest truth is that I’m too busy in the other areas of my life. It’s hard enough keeping up with the needs of my own family. This is in part why I wrote the book A Place to Start Without Sugar or Starch. It doesn’t have all the answers, but for anyone who has tried to contact me for specific guidance via email, my answer is likely within the pages of what I’ve already written.

It occurred to me that there may be other mother’s out there who would be interested in partnering with me to help continue the cause. Why start a whole new blog when you can just add to mine? I could also use someone savvy with a camera, as my recipe pictures could all use an update!

If you are interested, I would have a few simple parameters based on my Essential Carbohydrate philosophy.

CSIDRecipes Mom Partnership Criteria

  • Trial to include choosing 3-5 of the existing recipes on this site, providing feedback for any changes and taking high-quality photos to use for recipe promotion
  • No blog experience necessary, but helpful
  • Agreement to use pure ingredients and focus on healing foods (not simply reproducing mainstream processed foods). The exception would be special occasion treats on a case-by-case basis
  • We don’t use Sucraid, but I’m happy to publish recipes that require its use as long as they aren’t promoting the excess intake of sugar.
  • Provide a brief biography of your own CSID experience with a photo
  • I reserve the right to edit new posts prior to publishing to ensure they follow formatting and content parameters
  • This would be a free service to help others facing the challenges of CSID as you also learn new recipes and meal ideas for your self or family.

 

Second Edition of A Place to Start Without Sugar or Starch

A Place to Start Without Sugar or StarchI’ve finally published the second edition of my CSID Journey and Diet Guide on Amazon!

For those of you who purchased a copy of the first book, please know very little is changed besides the cover, a few minor wording details, and an update on our family’s progress. It’s also a lot less expensive than the First Edition, since I was able to use Create Space on Amazon and self-publishing has come a long way in a few short years.

I’d love to hear your comments and suggestions on this revised edition and look forward to your Reviews so that parents looking for a resource like this can trust it is what they need and want!

Read more on my BOOK INFO page.

I’m sorry that I wasn’t able to do a more thorough revamp, but I know it’s important to offer something tangible at this point. If you are looking for recipes after you’ve determined appropriate and tolerable foods, I highly recommend (and have several times in other posts), Practical Paleo and Against All Grain books. I envision you using A Place to Start Without Sugar or Starch alongside these cookbooks to tailor recipes and meal plans to your family’s individual needs.

I wish you wellness and happiness in the upcoming Holiday Season!

With CSID – Bad Days Are Inevitable

When Symptoms Change but Tolerance Doesn’t

I think we deceive ourselves only when we change what we can eat just based on that what we think we’re reacting to. In our family, we’ve learned the hard way that just because it doesn’t upset your stomach doesn’t mean it’s not upsetting something in our body.

As a Christian, I’ve learned about listening to the Holy Spirit and that if you don’t listen when you know you’re hearing the voice of God, that’s considered sin. It might be a spiritual consequence that we write off as worrying too much, or over-thinking. But for those of us who have lived long enough we know that when we do something on the contrary to what we know is right, eventually we suffer for it or the people around us do.

This is exactly what happens with dietary limits. Every time I think I can get away with eating something I know I shouldn’t end up suffering for it. And lately that’s suffering seems to come and more intense and immediate episodes.  I’ll get a migraine, or have extreme fatigue or irritability. Almost always I can trace it back to eating or drinking something that I probably shouldn’t have consumed.

The same goes for making exceptions to what my kids can eat.

Now that my oldest son has a positive Celiac diagnosis, we have one more reason to make our home gluten-free. But removing gluten alone doesn’t guarantee a healthy body any more than removing sugar for those with CSID guarantees symptoms will cease for good.

This week, I’m writing a blog on cellular health for Energetic Nutrition. As I research all the many processes and functions our cells go through, I’m learning of the thousands of possible scenarios that could cause a cell’s health to go awry. Of all the components required for a cell to work properly, good nutrition and the ability to combat negative influences are crucial. If the cell doesn’t have what it needs, it can’t duplicate in a healthy manner AND it can’t fight off harmful elements such as free radicals.

This takes me back to my original philosophy when it comes to CSID:

Add what helps, and remove what harms.

Of course, knowing what helps and what harms can be objective. There are many theories out there, and we have to decide what makes the most sense to us and our families. I don’t have access to current statistics, but it’s my understanding that starch tolerance levels can still be quite high for those with CSID. Primarily, sugar, or sucrose, tends to be avoided more than sources of starch.

However, as necessary as starch is as a form of carbohydrate, different types of starch can create very different results. Some forms of starch can cause digestive distress, such as those that come from grains or beans. Others, are dense sources of nutrients and relatively easy to digest, such as those from sweet potatoes or some root vegetables.

The difficulty is learning to know what each individual can manage and what symptoms, in addition to or besides digestive distress, to look for.

The alternative is deciding to eliminate or reduce potentially harmful foods or ingredients to avoid future problems.

For my family, I’ve found that incorporating a majority of Paleo-friendly foods into our household meal plan is beneficial for all of us. We receive ample sources of vegetables and proteins, healthy fats, only natural sources of sugar (fruit and occasional honey, coconut sugar, or maple syrup) and easy to digest carbohydrates. As we shift from our Summer Slide, and considering we now have a child with Celiac, all sources of gluten are gradually leaving our home.

This is the key to keeping me sane — deciding that what we offer in our home will be the ultimate source of health and healing. But not being so concerned with what is consumed away from home. My kids know what is helpful and harmful and are all at the ages where they need to learn to make their own decisions for health. If they give in to a food that could potential make them sick, they will learn their limits and have to decide differently the next time.

However, it is so easy to get discouraged! I also have those times where I think I’m making all the right decisions and dietary limitations and one of us still ends up having symptoms.  The truth is there are just way too many variables for us to control. And since we can’t physically see how everything from food, environment, or even emotional stress can effect each of our cells and ultimately, every system and defense mechanism in our bodies, we have to learn to accept the bad days along with the good ones. We have to do the best we can one day at a time, learn from our mistakes and compromises, and keep educating ourselves and making adjustments as needed.

As much as I still have to learn about digestive health and how it impacts every member of my family, I’m grateful for what I’ve learned in the past ten years about what can truly help and what can possibly harm. At least at the end of the day, I can know I did the best I could with the knowledge I had at the moment. And I believe my husband and my kids all appreciate my efforts and if they aren’t already, will be grateful for the efforts I made to provide them with the knowledge they need to make wise choices for their own health for years to come.

The Summer Slide – When Managing Celiac, CSID, and Allergies Goes Awry

With resources running low in recent months, it’s been difficult to feed my family the ideal diet. Summertime makes it all that much harder with teens coming and going and making their own choices regarding what to eat and drink when they are not home.

One thing that has made it difficult to keep taboo foods out of the house is that my oldest son, Dawson, is scheduled for a small bowel biopsy next week, and has doctor’s orders to eat gluten every day in order to confirm his Celiac diagnosis.

On the other hand, Parker (my youngest son and the reason I started this blog in the first place) had repeated food allergy tests done at the start of summer and is no longer “allergic” to wheat, eggs, or milk. Of course at 12 years old, he took that as a green light to eat all the wheat and milk he wants. When his GI Dr. said he didn’t see a problem with it due to the fact Parker has gained 10 pounds in the last year, I didn’t have a lot of ground to stand on to insist on continuing his modified diet.

So, this summer I’ve allowed our family to consume many of the foods I’d normally avoid and never allow in my home.

For those that don’t live with food allergies or sensitivities, this may seem like a blessing. But when as a whole, I begin to see signs and symptoms that may indicate distress among myself and my kids, I know it’s due to the over-consumption of processed foods.

Parker’s eczema has returned and although I’d hoped he’d be rash free on his first day of 7th grade, we haven’t been able to rid him of a few patches. Now, granted, he’s been swimming a lot and spending time outside in public areas with tons of grass, trees, and dogs around (all of which he is still allergic to). But he’s also been eating a lot of refined carbohydrates and drinking beverages with high-fructose corn syrup.

I could avoid sharing these details with the world, but the struggle is real. It’s not easy sticking to the ideal diet of select carbohydrates, clean meats, and plenty of fresh vegetables. Especially when my older teenage boys both end up with their first jobs at fast-food restaurants!

Back-to-School Means Back to Healthy!

So what is a mom to do? First, getting my husband to support the transition back to a Paleo-based diet at home is crucial. Since he experienced feeling better on a gluten-free diet last winter, this shouldn’t be too hard.

Second, between my own gluten sensitivity and our oldest son most likely having Celiac, we really need to remove gluten from the house to avoid cross-contamination.

This only leaves our middle son a “victim” due to his ability to eat anything. Yet, I believe he will also feel better, have more control over his hyperactive personality and do better in school.

However, to avoid burn out on my part, this is going to be a transition. School starts tomorrow so my plan is for the month of September, to focus on breakfast and dinner at home and allow the two boys without Celiac to eat school lunches. As fall approaches, I will assess the results and go from there.

Time to dust off my Paleo cook books and make a meal plan for the week.

Questions for you …

How hard is it for you to stick with a strict diet for yourself or your child(children) with dietary restrictions?

Do you find the medical community in support of extreme diet adjustments or are they indifferent to anything not backed by extensive research?

If you have a larger family or teens, I’d love to know of the ways you’ve been successful in feeding your family and encouraging healthy choices when not at home.

Candex May Help with Sugar Digestion

Epiphany Regarding Increased Sugar Tolerance in My Daughter

First of all, I want to express my sincere sympathy for those families suffering as a result of the Sucraid shortage. Our family has a high enough sucrose tolerance that we are able to use enzyme supplements from various nutritional companies to offset any excess sugar consumption. Though we all experience mild to moderate symptoms when we eat foods containing added sucrose (mostly cane sugar as we avoid high fructose corn syrup when possible). I won’t pretend to relate to those who have ZERO TOLERANCE TO SUGARS, even in natural foods such as fruit or root vegetables.

However, I wanted to share a ray of hope! My oldest daughter, diagnosed with CSID at 14, has always had very low sugar tolerance. She is still able to have some starches and grains in moderation, so she can take in enough carb-based calories. One of her chronic symptoms associated with CSID is recurring yeast infections. Since this form of yeast (Candida albicans) thrives on starch and sugar, I believe finding a way to minimize the overgrowth of this yeast could help curb this issue.

She is currently 22 years old a pregnant and I was concerned that she wouldn’t be getting enough calories once typical cravings set in. For us, I’ve noticed a pattern that leads to craving food we shouldn’t eat the more we partake in sugary or starchy foods. It’s actually not just a theory — sugar is an addictive substance. Especially the processed, white form.

Candex Enzymes for Intestinal HealthAnyway, before I go off on an anti-sugar rant, my daughter is an adult and makes her own choices. But I recently learned of a supplement, containing mostly enzymes, that supports digestive health by targeting the specific types of cells that make up Candida albicans. As a bonus, this supplement also contains Amylase, Invertase, and Glucomylase.– the enzymes that break down different forms of sugar!

CANDEX is manufactured by Pure Essence Labs and sold through various online retailers including Energetic Nutrition (my former employer and currently still a freelance client – but I get no form of compensation for mentioning this product).

After checking with her doctor and getting approval to take while pregnant, my daughter started taking Candex about a month ago. In a totally unrelated conversation a little over a week ago, she asked me if I’d ever heard of someone with CSID who experienced a higher tolerance to sugar while pregnant.

I told her honestly, I hadn’t been in touch with many adults with CSID or discussed their diets in enough detail to know. Then it occurred to me that she had been taking Candex (be it not consistently and not even on an empty stomach as recommended by the manufacturer). This is totally theory based on one individual, but this supplement may actually be helping my daughter to have a higher tolerance to sucrose! She had also lost weight in her first trimester but has gained 6 pounds in the past month.

Now, I don’t condone or encourage regular consumption of sugary foods – especially when the food itself only offers empty calories and no nutritional value. But I would like to offer this as a possible help in assisting with sucrose digestion.

Can Candex HELP THOSE WITH CSID?

The only way to know the answer to this is for others to be willing to try it. If the manufacturer can claim it is safe for pregnant women and children (note this is not a medical claim as they are not citing a specific disease), there is theoretically little risk.

However, I can only say that Candex appears to be helping in my own family. But if – and this is a BIG IF – others were willing to try it after consulting their health care provider or dietitian, and then to share the result in a comment on this blog, then maybe the answer could help others.

Side Note on the Differences Between FDA-Approved Drugs and Nutritional Supplements

Nutritional supplements (such as Candex) are not approved by the FDA. One reason being the loopholes supplement companies would have to jump through (current Sucraid shortage point in case) to get approval. Another being that the natural ingredients that comprise supplements vary due to them being – well – natural  and not created in a lab. And a third reason is that the FDA only approves DRUGS used to treat disease or symptoms of disease. They don’t approve natural remedies that can help prevent imbalances that may lead to disease, or bring a body back into balance after experiencing illness or stress. FDA approval does NOT mean that the drug is safe or doesn’t have side-effects. It means that they have determined the benefits of a drug outweigh the risks or side-effects in taking it.

With that said, there are many nutritional supplement companies out there that have gone above and beyond in order to show consumers that they can manufacture products of high-quality and with safety standards. This means using pure ingredients, minimal fillers or additives, and testing for quality. But no matter how many trials or scientific studies may indicate a certain supplement may help with a specific health issue, they are not permitted to make a medical claim in describing their product.

This is a nutshell explanation and is actually very complicated. But I’ve spent the better part of the past year having to re-write product descriptions for Energetic Nutrition to comply with this standard of DSHEA (Dietary Supplement Health and Education Act). I have yet to finish revisions on this blog as a result, but I wanted to explain that any vague or non-specific descriptions are a result of this Act.

Your thoughts?

I’d love to hear your thoughts and questions about taking supplements for digestive health. Regardless of how well we curb our children’s or our own diets to compensate for CSID, taking something to help support healthy digestion, or assist our bodies in reducing symptoms associated with poor digestion, seems like a smart choice to me.

QOL Responds to Sucraid Shortage – Time Sensitive!

*Please note this is time sensitive information. Updates will be posted as they are available.

Sucraid Shortage and QOL Response Summary

SUCRAID® SHORTAGE UPDATE

Conference Call with QOL Medical CEO Derick Cooper on April 13, 2016 at 2 p.m. (EST)

For current information on Sucraid and QOL updates, visit the following websites:

The following are highlights and follow-up on Q&A from the Conference Call

The listed questions were provided to Mr. Cooper in advance. Some were answered in conjunction with others during the conference call so not every question is answered precisely, but is addressed at one point or another. I’ve noted a reference to the answer for another question when it applies.

(Note: I’ve done my best to present this information in an objective manner and to state the information provided by Mr. Cooper as accurately as possible for informational purposes only.)

  1. Could QOL Medical clarify the reason for the shortage? Is it related to a combination of factors or primarily one?
    Information known prior to the conference:
    a) Ingredient related: The FDA website statement mentions “shortage related to unavailable approved active pharmaceutical ingredient (API) from a supplier due to requirements related to complying with good manufacturing process.”
    b) New facility and production related: Letter by QOL Medical CEO March 2016 mentions the construction of an entire new facility and transfer of production to entirely new building.
    ANSWER: Mr. Cooper further explained the change in facilities was to transfer the production of the primary ingredient in Sucraid – sacrosidase – from a food-grade manufacturing facility to a pharmaceutical-grade facility per FDA request.
  2. Reason behind the decision to change production which resulted in the shortage: Sucraid has been produced for years and used by patients for 17+ years. If the formulation hasn’t changed at all, what happened now, to get us to where we are now?
    ANSWER: Sacrosidase originally made in a food-grade facility that no longer met pharmaceutical standards. QOL has rebuilt a new facility to meet all current standards. They are working on details for final approval to begin manufacturing with FDA. Although the production of the ingredient met FDA requirements prior to this change, QOL is now  “migrating manufacturing to meet modern standards”. Mr. Cooper mentioned that there are “items” to finalize with FDA within the week,  but did not mention what those details were.
    According to Mr. Cooper, the  requirements to manufacture pharmaceutical-grade products involve two steps: 1) Tests of ingredient itself after processing to ensure that the product still effective, and no contaminants were introduced  during the process. 2) Manufacturing process itself is very complicated. Mr. Cooper did his best to describe the general steps involved as an example to demonstrate the details and steps involved in the migration. They start with a lot of yeast, then extract the sacrosidase from the yeast and filter multiple times to ensure only sacrosidase is left in a pure form. The filter must be checked by outside vendor who has valid methods for checking filter. Each part of this process needs to be documented and submitted to the FDA. QOL has made valiant efforts to follow these procedures and paperwork requirements the entire time. FDA regulations are ever-changing and do not always apply to each specific product produced. These guidelines are subject to interpretation, and QOL has done their best to interpret the guidelines according to the specific process and manufacturing of sacrosidase (Sucraid). The FDA and QOL are working together to expedite the process as much as possible.
  3. What does QOL Medical see as the current status of the shortage? Can you expand on the below information?
    Information known prior to the conference:
    a) Letter by QOL Medical CEO March 2016 mentions “we have built this new facility, transferred the manufacturing process, begun production, and filed the necessary regulatory application with the FDA for approval. We have produced Sucraid® in the new facility and are awaiting final regulatory approvals for distribution.”
    b) Calls to Sucraid Assist / One Patient Services mentioned new facility has already produced Sucraid but that those lots have not been FDA approved.
    c) Accredo representative has stated the shortage prolongation is due to the FDA not approving an ingredient in Sucraid.
    To clarify, it was the production of the main ingredient, sacrosidase within a food-grade facility the FDA decided needed to take place in a pharmaceutical-grade facility which promoted the changes. QOL did not anticipate the building and transfer to new facilities taking so long, which is the assumed reason they did not manufacture enough Sucraid prior to the transfer to meet the demand. This is my interpretation of what seemed to be implied by Mr. Cooper.
  4. FDA states they are awaiting information from QOL in order to approve Sucraid lots. What are they waiting for? As of today, all paperwork has been turned in and inspection of facility is complete. There are a few minor details (not specified by Derek) that will be address tomorrow (April 14, 2016)  in a meeting between QOL and FDA for final resolution.
    ANSWER: At the time of the phone conference, FDA had completed a full inspection of the new facility and QOL had completed and submitted all required paperwork.
  5. Does QOL anticipate a foreseeable end date to shortage?
    ANSWER: Though this could not be answered precisely, Mr. Cooper said it could take up to 2-3 months before Sucraid is available again, but he was hopeful it would be sooner.
  6. Can QOL Medical provide an estimated timeline for a resolution of the shortage in terms of weeks, months or longer? Patients would like to know if they should plan to be without Sucraid for a short, medium or long period of time. They are cognizant any specific timeline is unlikely as it will invariably change.
    See ANSWER TO #5.
  7. How can the most vulnerable patients be prioritized to receive any available, or first available, Sucraid? For the families who have quit using Sucraid to make it more available to more at risk patients, how will it be communicated to us that there is enough to begin using it again?
    There are some units left they are saving for these patients according to dire need, however they will not use this supply if they are able to begin manufacturing a new batch soon.
  8. Does QOL have any data about other medications that experienced a similar facility approval related shortage situation? If so, what was the timeframe for those similar cases to be resolved? When it is released, it will be available within a week of FDA approval. NA
  9. Can QOL confirm that all Sucraid that has been currently released is only done with full FDA approval?
    Information known prior to the conference:
    a) That there are NO unapproved lots in circulation.
    b) That Sucraid lots requiring an informed consent listed additional possible risks but were still approved as safe to be released by the FDA.
    c) That current Sucraid is safe to use and that all possible risks have been fully disclosed in writing to patients. That neither QOL nor the FDA has hidden any important information from them.
    d) FDA stated this clearly in the teleconference, but the point seems to have still been confused by other external statements on the call and noise distraction.
    Details related to this question were not addressed specifically enough for me to confirm or deny the details.
  10. Even though it was FDA approved as safe to use with informed consent, What were the specific contaminants that were identified or posed as possible risks?
    ANSWER: I asked Mr. Cooper to clarify this once the call was opened to questions. If I understood him correctly, it was the “manufacturing of sacrosidase” that no longer met FDA requirements. There was NOT any contamination of the ingredient.

It’s possible the FDA was concerned the food-grade facility could lead to a risk which is why they prompted the move to new pharmaceutical grade facilities, but this inference was not made by Mr. Cooper himself.

ADDITIONAL DETAILS SHARED DURING THE CALL

To clarify the frustration of one parent on why they were not informed of the possible shortage in advance, Mr. Cooper explained that QOL doesn’t have the ability to directly contact patients due to HIPPA.

Possible Solutions to Communicating with Parents and Patients in the future  Not Explored during the call: Communicating in general with pharmacies, doctors, or insurance companies OR placing a notice in the packaging of Sucraid when this process started, letting patients know that a shortage was possible.

In answer to another caller’s question, Mr. Cooper clarified that this transfer to new facilities would not impact the cost of Sucraid or change any current programs designed to assist families in need.

Mr. Cooper ended the call by stating that QOL would love to hear stories about how Sucraid has made a difference. Again, they are doing all they can to expedite this approval process as soon as possible, and they are deeply sorry for the issues this shortage has caused to families.

Getting diagnosed with CSID as an adult or teen

As difficult as it is for parents to adjust to feeding their young child with a recent CSID diagnosis, suspecting or receiving a CSID diagnosis is even harder as a teen or adult. Babies and young children have the advantage of never knowing a life of consuming excess sugar or starch. If regulated and monitored, they will at least know how beneficial living without these foods can be. Even if they experiment as older teens or adults, they will quickly learn their tolerance levels and have their childhood lessons on proper food choices to fall back on

My miserable teen years

I often reflect back to my teen years and a point where I was so frustrated from getting an upset stomach or gas every time I ate, I wished I could just take a pill to satisfy my hunger. Eating has rarely been a pleasure for me. I used to blame it on stress alone, and I’m sure stress played a part, but if I had only known how to curb some of my common eating habits at a younger age – I wonder how different my life would look now.

You see, it wasn’t until after two of my children were diagnosed with CSID and I decided I would only eat what they could as I began experimenting with recipes, that I realized I, too, likely had CSID. But that was back in 2007 when I was a stay-at-home-mom and my time and financial resources were plenty.

Confirming what I already knew

Finally, a visit with the genetics department and a GI doctor back in 2014 confirmed my suspicions. However, there still wasn’t a pill out there that could help my cause! I had to make a daily choice – meal by meal – and avoid those foods I knew were harmful to me. I also learned that if I chose to continue consuming gluten or sugar (at that point I thought that moderation wouldn’t hurt me) – that it could lead to other problems. Eventually I realized my fibromyalgia symptoms were linked to gluten and sugar consumption as well. Beyond stomach upset, consuming taboo foods could also trigger a flare-up of chronic pain, severe PMS, or a migraine that lasted for days.

Bad habits die hard

But curbing poor eating habits and fighting the urge to consume what’s in front of me (especially when hunger demanded I eat something) is easier said than done. Despite knowing I am setting an example for my teenage and adult children (they are ages 12-22 as of the date of this post), I still give in on occasion – and always pay a price.

However, after experiencing a horrible migraine the day before heading off on a week-long writer’s conference at the end of March, my resolve strengthened. Enough is enough – I must learn to care for my own digestive health in hopes that my children will see me benefiting and make their own wise choices. (See PREPARING FOR THE 21-DAY SUGAR DETOX  to read more on my own commitment to change.)

A new reason to get well – I’m going to be a grandmother!

My oldest daughter is pregnant and constantly hungry  while she and her husband balance working 2 jobs each. Now that we are living close to each other, I desire to model proper eating habits regardless of the chaos of life. With a grandchild on the way, my motivation is stronger than ever. I want to be healthy and capable of spending as much time with him or her as possible!

 

Digestive Enzyme Deficiency Support

During the better part of the past year, I have had the privilege of working for an online retailer of various brands of high-quality supplements. Part of my job has been to write or rewrite their blog content and one of my first projects was to write a blog on digestive enzyme deficiency. My boss was eager for me to share my knowledge related to CSID with their general readership and we both learned a lot in the process.

I have posted the first part here with a link to read the entire article on the Energetic Nutrition blog.

Finding Support for Digestive Enzyme Deficiency

More than Occasional Tummy Troubles

A healthy, fully functioning digestive system provides essential detoxification, immune system support, and energy from the proper breakdown of food. It is a well-known fact that over 70% of our immune system is located in our digestive tract.

Many times symptoms of compromised digestion do not become apparent until disease or chronic illness are present.

If the digestive system is unable to function properly, various symptoms can surface from something as simple as occasional stomach ache, acid indigestion, or flatulence to more serious chronic conditions such as food allergies or digestive disease.

When digestive problems begin to interfere with everyday life, a quick, over-the-counter solution may be the first line of defense. However, these remedies often only cover up symptoms and do not address the root of digestive distress. For long-term results, adding digestive enzyme supplements can provide the body with added digestive support in addition to alleviating symptoms.

CONTINUE READING AT ENERGETIC NUTRITION/BLOG