Jump to content

  • Welcome to Celiac.com!

    You have found your celiac tribe! Join us and ask questions in our forum, share your story, and connect with others.



  • Celiac.com Sponsor (A1):

    Celiac.com Sponsor (A1-M):

  • Get Celiac.com Updates:
    Support Our Content
    eNewsletter
    Donate

At-1001 Clinical Trial

Swingin' Celiac

Recommended Posts

Swingin' Celiac Newbie
Swingin' Celiac
Posted

I'm thinking about participating in a clinical trial for the new experimental celiac disease drug by Alba Therapeutics AT-1001 (a.k.a larazotide acetate). From what I've read, it appears that the drug is not supposed to be a substitute for a gluten-free diet, but would be useful for protecting us from a small amount of gluten in the case of cross-contamination.

Anyway, the drug is in Phase IIb of clinical trials, so it has already been tested on a few different groups of people. So far, there haven't been any serious side effects or "adverse events" reported. However, the number of people in previous trials was not particularly great maybe a few hundred or so, so they can't guarantee anything.

I'm not exactly sure what to do. I'm all for the progress of science, especially in the field of celiac disease research and it would be cool to be a hero for the cause. However, I don't think I should just jump into this blindly. When I first heard about the drug, I was under the impression that I'd be able to eat bread again and was like "sign me up", but that doesn't seem to be the case. Although I wouldn't have to be quite so paranoid about CC which would be nice. In the test, I'd still be required to maintain my gluten-free diet, I'd take the pill three times a day, and I'd have to get a total of two upper endoscopies/biopsies (one at the beginning and end of the study). Personally, I think that the greatest risk would be from the endoscopies, but at least in that case you know the risks going in. Anyway, do you think it would be worth the risk? Any insights into clinical trials in general or AT-1001 in particular?

One other confusing thing. They said that they would do a blood test to make sure that I was adhering to a gluten-free diet, but that they would also do an endoscopic biopsy to make sure I had "Active Celiac Disease." Now I was under the impression that one had to be eating gluten in order for celiac disease to be diagnosed via biopsy, but they told me to stay on a gluten-free diet. Am I missing something? I thought healed gluten-free celiac disease intestines were virtually indistinguishable from healthy non-celiac disease intestines. Anyway, just me being curious.

Celiac.com Sponsor (A8):
Celiac.com Sponsor (A8):

Celiac.com Sponsor (A8-M):


gfp Enthusiast
gfp
Posted
I'm thinking about participating in a clinical trial for the new experimental celiac disease drug by Alba Therapeutics AT-1001 (a.k.a larazotide acetate). From what I've read, it appears that the drug is not supposed to be a substitute for a gluten-free diet, but would be useful for protecting us from a small amount of gluten in the case of cross-contamination.

Anyway, the drug is in Phase IIb of clinical trials, so it has already been tested on a few different groups of people. So far, there haven't been any serious side effects or "adverse events" reported. However, the number of people in previous trials was not particularly great maybe a few hundred or so, so they can't guarantee anything.

I'm not exactly sure what to do. I'm all for the progress of science, especially in the field of celiac disease research and it would be cool to be a hero for the cause. However, I don't think I should just jump into this blindly. When I first heard about the drug, I was under the impression that I'd be able to eat bread again and was like "sign me up", but that doesn't seem to be the case. Although I wouldn't have to be quite so paranoid about CC which would be nice. In the test, I'd still be required to maintain my gluten-free diet, I'd take the pill three times a day, and I'd have to get a total of two upper endoscopies/biopsies (one at the beginning and end of the study). Personally, I think that the greatest risk would be from the endoscopies, but at least in that case you know the risks going in. Anyway, do you think it would be worth the risk? Any insights into clinical trials in general or AT-1001 in particular?

One other confusing thing. They said that they would do a blood test to make sure that I was adhering to a gluten-free diet, but that they would also do an endoscopic biopsy to make sure I had "Active Celiac Disease." Now I was under the impression that one had to be eating gluten in order for celiac disease to be diagnosed via biopsy, but they told me to stay on a gluten-free diet. Am I missing something? I thought healed gluten-free celiac disease intestines were virtually indistinguishable from healthy non-celiac disease intestines. Anyway, just me being curious.

Hmmm, not sure a clinical trial is actually science !!!

They seem (reading what you said) to actually only take people who are gluten lite .. not 100% gluten-free.

If they were actually interested in 'science' as opposed to ONLY the bottom line they would be doing a lot research on 100% gluten-free people...

However if they did that they would have to come up with a baseline for the blood tests for someone who is actually gluten-free not gluten-lite and I suspect that they suspect this will mess up their results.

I say they suspect since they probably haven't tested ... which answers your question really about clinical trials...

The trials are done to prove a drug works ... not for science or the benefit of the population etc. but for the bottom line of the company.

The worlds most successful drug marketing campaign is said to be (according to Harvaard Business School) Ranitidine (Zantac) ...

Glaxo-Welcome spent millions developing the ideal drug (didn't cure ANYTHING but had a life long dependency) ...

Most of the way through their research two austrailian Dr's published a paper on h. pylori and how most ulcers can be cured by 25c worth of antibiotics. Glaxo-welcome then spent more millions paying off Dr's and bullying scientific journals, hiring 'PI's' to intimidate the Dr's and trying to dig up dirt...

Eventually .... (after an estimated several hundred thousand deaths from ulcers) the australian government actually interceded... and forced an open press in Australia ... this snowballed until their were investigations etc. in the scientific publishers (blackwell, elsevier etc.) ... and the publishers were found to be biassed towards their advertisers (like it needs an investigation)....

Archived

This topic is now archived and is closed to further replies.

Go to topic listing

  • Get Celiac.com Updates:
    Support Celiac.com:
    Join eNewsletter
    Donate
  • Celiac.com Sponsor (A17):
    Celiac.com Sponsor (A17):



    Celiac.com Sponsors (A17-M):



  • Recent Activity

    1. SamAlvi
      - SamAlvi replied to SamAlvi's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      7

      High TTG-IgG and Normal TTG-IgA

      Thanks again for the detailed explanation. Just to clarify, I actually did have my initial tests done while I was still consuming gluten. I stopped eating gluten only after those tests were completed, and it has now been about 70 days since I went gluten-free. I understand the limitations around diagnosing NCGS and the importance of antibody testing...
    2. knitty kitty
      - knitty kitty replied to lizzie42's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      6

      Son's legs shaking

      Blood tests for thiamine are unreliable. The nutrients from your food get absorbed into the bloodstream and travel around the body. So, a steak dinner can falsely raise thiamine blood levels in the following days. Besides, thiamine is utilized inside cells where stores of thiamine are impossible to measure. A better test to ask for is the Erythrocyte...
    3. lizzie42
      - lizzie42 replied to lizzie42's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      6

      Son's legs shaking

      Neither of them were anemic 6 months after the Celiac diagnosis. His other vitamin levels (d, B12) were never low. My daughters levels were normal after the first 6 months. Is the thiamine test just called thiamine?
    4. knitty kitty
      - knitty kitty replied to lizzie42's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      6

      Son's legs shaking

      Yes, I do think they need a Thiamine supplement at least. Especially since they eat red meat only occasionally. Most fruits and vegetables are not good sources of Thiamine. Legumes (beans) do contain thiamine. Fruits and veggies do have some of the other B vitamins, but thiamine B 1 and Cobalamine B12 are mostly found in meats. Meat, especially organ...
    5. lizzie42
      - lizzie42 replied to lizzie42's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      6

      Son's legs shaking

      Thank you! That's helpful. My kids eat very little processed food. Tons of fruit, vegetables, cheese, eggs and occasional red meat. We do a lot of rice and bean bowls, stir fry, etc. Do you think with all the fruits and vegetables they need a vitamin supplement? I feel like their diet is pretty healthy and balanced with very limited processed food....
  • Celiac.com Sponsor (A19):

  • Member Statistics

    • Total Members
      132,874
    • Most Online (within 30 mins)
      7,748
    Jen J.
    Newest Member
    Jen J.
    Joined
  • Celiac.com Sponsor (A20):
  • Celiac.com Sponsor (A22):

  • Forum Statistics

    • Total Topics
      121.5k
    • Total Posts
      1m
  • Celiac.com Sponsor (A21):

  • Upcoming Events

  • Posts

    • SamAlvi
      High TTG-IgG and Normal TTG-IgA

      By SamAlvi · Posted

      Thanks again for the detailed explanation. Just to clarify, I actually did have my initial tests done while I was still consuming gluten. I stopped eating gluten only after those tests were completed, and it has now been about 70 days since I went gluten-free. I understand the limitations around diagnosing NCGS and the importance of antibody testing and biopsy for celiac disease. Unfortunately, where I live, access to comprehensive testing (including total IgA and endoscopy with biopsy) is limited, which makes things more complicated. Your explanation about small-bowel damage, nutrient absorption, and iron-deficiency anemia still aligns closely with my history, and it’s been very helpful in understanding what may be going on. I don't wanna get Endoscopy and I can't start eating Gluten again because it's hurt really with severe diarrhea.  I appreciate you taking the time to share such detailed and informative guidance. Thank you so much for this detailed and thoughtful response. I really appreciate you pointing out the relationship between anemia and antibody patterns, and how the high DGP IgG still supports celiac disease in my case. A gluten challenge isn’t something I feel safe attempting due to how severe my reactions were, so your suggestion about genetic testing makes a lot of sense. I’ll look into whether HLA testing is available where I live and discuss it with my doctor. I also appreciate you mentioning gastrointestinal beriberi and thiamine deficiency. This isn’t something any of my doctors have discussed with me, and given my symptoms and nutritional history, it’s definitely worth raising with them. I’ll also ask about correcting deficiencies more comprehensively, including B vitamins alongside iron. Thanks again for sharing your knowledge and taking the time to help. I’ll update the forum as I make progress.
    • knitty kitty
      Son's legs shaking

      By knitty kitty · Posted

      Blood tests for thiamine are unreliable.  The nutrients from your food get absorbed into the bloodstream and travel around the body.  So, a steak dinner can falsely raise thiamine blood levels in the following days.  Besides, thiamine is utilized inside cells where stores of thiamine are impossible to measure. A better test to ask for is the Erythrocyte Transketolace Activity test.  But even that test has been questioned as to accuracy.  It is expensive and takes time to do.   Because of the discrepancies with thiamine tests and urgency with correcting thiamine deficiency, the World Health Organization recommends giving thiamine for several weeks and looking for health improvement.  Thiamine is water soluble, safe and nontoxic even in high doses.   Many doctors are not given sufficient education in nutrition and deficiency symptoms, and may not be familiar with how often they occur in Celiac disease.  B12 and Vitamin D can be stored for as long as a year in the liver, so not having deficiencies in these two vitamins is not a good indicator of the status of the other seven water soluble B vitamins.  It is possible to have deficiency symptoms BEFORE there's changes in the blood levels.   Ask your doctor about Benfotiamine, a form of thiamine that is better absorbed than Thiamine Mononitrate.  Thiamine Mononitrate is used in many vitamins because it is shelf-stable, a form of thiamine that won't break down sitting around on a store shelf.  This form is difficult for the body to turn into a usable form.  Only thirty percent is absorbed in the intestine, and less is actually used.   Thiamine interacts with all of the other B vitamins, so they should all be supplemented together.  Magnesium is needed to make life sustaining enzymes with thiamine, so a magnesium supplement should be added if magnesium levels are low.   Thiamine is water soluble, safe and nontoxic even in high doses.  There's no harm in trying.
    • lizzie42
      Son's legs shaking

      By lizzie42 · Posted

      Neither of them were anemic 6 months after the Celiac diagnosis. His other vitamin levels (d, B12) were never low. My daughters levels were normal after the first 6 months. Is the thiamine test just called thiamine? 
    • knitty kitty
      Son's legs shaking

      By knitty kitty · Posted

      Yes, I do think they need a Thiamine supplement at least. Especially since they eat red meat only occasionally. Most fruits and vegetables are not good sources of Thiamine.  Legumes (beans) do contain thiamine.  Fruits and veggies do have some of the other B vitamins, but thiamine B 1 and  Cobalamine B12 are mostly found in meats.  Meat, especially organ meats like liver, are the best sources of Thiamine, B12, and the six other B vitamins and important minerals like iron.   Thiamine has antibacterial and antiviral properties.  Thiamine is important to our immune systems.  We need more thiamine when we're physically ill or injured, when we're under stress emotionally, and when we exercise, especially outside in hot weather.  We need thiamine and other B vitamins like Niacin B 3 to keep our gastrointestinal tract healthy.  We can't store thiamine for very long.  We can get low in thiamine within three days.  Symptoms can appear suddenly when a high carbohydrate diet is consumed.  (Rice and beans are high in carbohydrates.)  A twenty percent increase in dietary thiamine causes an eighty percent increase in brain function, so symptoms can wax and wane depending on what one eats.  The earliest symptoms like fatigue and anxiety are easily contributed to other things or life events and dismissed.   Correcting nutritional deficiencies needs to be done quickly, especially in children, so their growth isn't stunted.  Nutritional deficiencies can affect intelligence.  Vitamin D deficiency can cause short stature and poor bone formation.   Is your son taking anything for the anemia?  Is the anemia caused by B12 or iron deficiency?  
    • lizzie42
      Son's legs shaking

      By lizzie42 · Posted

      Thank you! That's helpful. My kids eat very little processed food. Tons of fruit, vegetables, cheese, eggs and occasional red meat. We do a lot of rice and bean bowls, stir fry, etc.  Do you think with all the fruits and vegetables they need a vitamin supplement? I feel like their diet is pretty healthy and balanced with very limited processed food. The only processed food they eat regularly is a bowl of Cheerios here and there.  Could shaking legs be a symptom of just a one-time gluten exposure? I guess there's no way to know for sure if they're getting absolutely zero exposure because they do go to school a couple times a week. We do homeschool but my son does a shared school 2x a week and my daughter does a morning Pre-K 3 x a week.  At home our entire house is strictly gluten free and it is extremely rare for us to eat out. If we eat at someone else's house I usually just bring their food. When we have play dates we bring all the snacks, etc. I try to be really careful since they're still growing. They also, of course, catch kids viruses all the time so I  want to make sure I know whether they're just sick or they've had gluten. It can be pretty confusing when they're pretty young to even be explaining their symptoms! 
×
×
  • Create New...

Important Information

NOTICE: This site places This site places cookies on your device (Cookie settings). on your device. Continued use is acceptance of our Terms of Use, and Privacy Policy.