Jump to content
This site uses cookies. Continued use is acceptance of our Terms of Use and Privacy Policy. More Info... ×

  • 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
  • Celiac.com Sponsor (A19):


  • Member Statistics

    • Total Members
      126,216
    • Most Online (within 30 mins)
      7,748
    cboling
    Newest Member
    cboling
    Joined
  • Celiac.com Sponsor (A20):

  • Forum Statistics

    • Total Topics
      120.9k
    • Total Posts
      69.2k
  • Celiac.com Sponsor (A22):



  • Celiac.com Sponsor (A21):


  • Upcoming Events

  • Posts

    • knitty kitty
      Has anyone had terrible TMJ/ Jaw Pain from undiagnosed Celiac?

      By knitty kitty · Posted

      @Milarynn,  Welcome to the forum!   Many undiagnosed, untreated Celiac Disease patients have vitamin and mineral deficiencies.  Be sure to have your Vitamin D level checked.  Vitamin D helps prevent bone loss, including loss from the jaw and teeth.   Magnesium and calcium are both important to bone health as well.  Magnesium helps keep the calcium from leaving your bones.  Magnesium helps make life sustaining enzymes with Thiamine Vitamin B1.  Low Magnesium and/or low Thiamine results in muscle cramping.   Thiamine deficiency is found in Pre-diabetes and Diabetes.  Poor absorption of the eight water soluble B vitamins and Vitamin C are found in Celiac Disease.  Insufficient Vitamin C can cause poor oral health, resulting in poor gum health such as receding and bleeding gums.  Vitamin C is needed to fight bacteria that cause plaque which causes cavities.  Vitamin C helps rebuild tooth enamel.   I've had jaw muscle cramping, TMJ problems, tooth loss and gum problems.  Do talk to your dentist about having Celiac Disease.  Practice good oral hygiene.  I'm also Diabetic and take Benfotiamine (a form of Thiamine) that helps regulate blood glucose and heal the intestines. Do keep us posted on your test results and your progress!
    • trents
      Has anyone had terrible TMJ/ Jaw Pain from undiagnosed Celiac?

      By trents · Posted

      Milaryrnn, your post is confusing. First, your celiac disease antibody testing is negative. By any chance had you already been on a gluten free diet before the blood draw for these tests was done? That would result in negative antibody testing even if you had celiac disease. Or, had you previously been diagnosed with celiac disease and had the antibody testing done to check for compliance with the gluten free diet? Second, DNA testing cannot be used to confirm celiac disease. 40% of the general population has the genetic potential to develop active celiac disease but only about 1% of the population actually develops active celiac disease. It takes both the genetic potential and some triggering biological stress event in order to develop active celiac disease. Otherwise, the genes remain inactive. High lipase levels would indicate some problem with your pancreas. 
    • More2Learn
      Celiac Maybe a Possibility?

      By More2Learn · Posted

      Thanks, yes, I've gone back and forth.  There is a lot of autoimmune disease in my family, so primarily I was thinking a real diagnosis might be helpful for other family members -- especially as I have two young biological nephews.  I feel like I am at a crossroads, where if I'm going to test now would be the time, since I've been in a less-than-perfect eating period.  I'm either going to just going to use what I've learned in these last few months to purposely never cheat again (obviously there is the accidental glutening situations) or test first, and then do that.  I don't need an official diagnosis so much that if I'm doing well I'm going to sabotage that by then starting to eat gluten again. I'm so glad you said this.  Even from what I've read so far, it makes sense to me that this is a misconception.  But growing up with all kinds of allergies, I can see how, as for the general population it's just easier for everyone to simplify it down to a type of "allergy," people would assume this.  It's just how most people look at allergies and diets and gluten avoidance has been painted as both.  I even see it in my journey to date, when I say I want a gluten free selection at a restaurant and I am asked "is it an allergy?" and it is so much easier just to say yes (even if the answer is actually well, no, it's autoimmune).  Because the "yes" answer is the "this is serious" answer.
    • Milarynn
      Has anyone had terrible TMJ/ Jaw Pain from undiagnosed Celiac?

      By Milarynn · Posted

      Hello. I recently had an endo/colonoscopy and my GI Dr found lymphocytes in my stomach and small intestine. My TTG Ab, IgA was <2 (normal), GLIADIN (DEAMINATED) IGA at 5 (negative), and IgA at 237 (normal). However, a Lipase test revealed my levels were through the roof at 201, 3x above normal. My GI doctor ordered a dna test to confirm Celiac Disease. An A1C test was also done and I am pre-diabetic. When I got home from work today, I started to feel sever cramping in my jaw muscles. I started to have jaw muscle cramps in the the last year. Not to mention, even with good oral hygiene, I have rapidly developed periodontal disease. I did have a small amount of gluten, thinking it wouldn’t harm much but I was sadly mistaken. DNA results should be back in 2 weeks. 
    • kopiq
      starting to heal, vitamin d deficiant but cannot tolerate vitamins. what to do? also multiple ongoing issues.

      By kopiq · Posted

      I also have food particles left on toiet paper when i wipe and my stool is light yellow not absorbing fats. I urinate about 15 times a day and have very sticky snot,dry throat.
×
×
  • Create New...