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Saturday, March 28, 2009
Celiac Disease Clinical Trial
How do you feel about celiac disease clinical trials?

I got an email today announcing a Celiac Disease clinical trial. I have very mixed feelings about this kind of study. I do appreciate that researchers are trying to work to make the life of a Celiac more "normal" but the idea of eating controlled amounts of gluten during this trial makes me very nervous. After being on a gluten-free diet since 1981, I don't think I could knowingly sit down and eat food that I know will send me to the bathroom and then the bed in less than an hour. Also, don't trials usually consist of a control group and another group that is taking a placebo? What if you are in the placebo group? Here, take this pill that might not do anything but eat gluten anyway. No thanks. In addition, I wonder if this pill will mask the side effects of gluten like Lactaid does for someone that is lactose-intolerant. That might be nice but isn't the gluten still damaging you on the inside?

In the grand scheme of auto-immune diseases I think we are quite lucky that we can control our disease by a diet. We aren't dependent on medication like my friends with thyroid diseases, diabetes, and rheumatoid arthritis are on a daily basis. We are not getting nurse-administered IV drips every six weeks like my friend with Lupus. We are going to a grocery store, shopping for food, and then being cautious of what we ingest. Simple. (Yes, I do realize that to many people that are newly diagnosed with Celiac Disease that it is not that simple. But look at the alternatives I listed above)

My sister and I often talk about if we would eat gluten if a pill became available. Right now I can honestly say that I would not take this which is why I am not a good candidate for the clinical trial. You might be though, so here is the trial information.

Alba Therapeutics Corporation Announces the Next Clinical Trial of its Lead Compound, Larazotide Acetate and Promotions

BALTIMORE, MD. March 17, 2009/PRNewswire - Alba Therapeutics Corporation announced today it will initiate further clinical studies for patients diagnosed with celiac disease with their lead compound, larazotide acetate. “Our most recent Phase IIb study, the largest trial with an investigational medication conducted in patients with celiac disease, was a randomized, double-blind, placebo controlled, dose ranging, multicenter study to determine the safety, tolerance and efficacy of larazotide acetate in 184 adults with controlled celiac disease during a gluten challenge. The data are promising and will be publicly presented at upcoming scientific meetings this spring,” said Bruce Peacock, CEO of Alba Therapeutics. “Recently, Alba restructured to concentrate its efforts on advancing the clinical program for larazotide acetate and we are now moving forward with initiating our next clinical trial in patients with celiac disease.”

If you are age 18-72, have proven Celiac Disease, and have had relief from your systems on a gluten-free diet you may qualify. There are trials in 11 states and two Canada locations. Please visit to see if you are qualified to participate in this survey. If you have any questions please call Bob Farley at 1-800-342-9102.

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Awesome post! When I heard about Alba Pharm's drug for those of us with celiac disease, I was excited at first. The possibility of eating gluten again (whatever I wanted and wherever I wanted) was mind blowing! After I thought about it more, taking medication in order to eat something my body rejects just doesn't seem right to me. We are "lucky" enough to have an autoimmune disorder that can be "fixed" through diet. Sure it's hard at times, but I'd rather be medication-free and healthy. Drug side-effects scare me a bit - especially a new drug on the market. I think I'll continue just as I am - gluten free!

Blogger Unknown said...

Hey Maureen, thanks for the comment. I think there would be a lot of people desperate to try miracle gluten pill, but not me at this point in my life.

Anonymous Kelly said...

Amen, Sistah! I agree with you. I'm actually grateful that this diet has taught me to be conscious about what I put in my body. I'm not sure I would have ended up like this unless I had to from being sick in the beginning. Most people would rather pop a pill know, since "America Runs On Dunkin". I laugh at that slogan every time I see it.

Blogger I Am Gluten Free said...

I am in agreement with the prior three comments. I am grateful that by simply changing my diet, I can be healthy again. Why put something in your body that your body rejected in the first place? Doesn't make sense to me.


Blogger Linda said...

I participated in one of the earlier trials. We didn't know when we were eating gluten. It was hidden in pudding and we didn't know which day it would be in there. I think I had a placebo because I got sick. It's possible that triggered my Hashimoto's thyroid disease which came on soon after that.

I think that one target group for this pill is teens who don't have the same convictions that adults do about their health. It would also be useful to have when eating out just in case there is contamination. But I have to admit, I wouldn't mind an occasional gluten treat. Would I really be able to eat it though? I don't know.

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