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Larazotide Acetate in Patients With Celiac Disease Undergoing a Gluten Challenge

Celiac.com 02/04/2013 - Ever wonder what happens to all those celiac disease patients who volunteer to do a gluten-challenge in the name of science? Well, the short answer is that they likely suffer, and may incur gut damage, at least in the short term.

Photo: CC--CeresBA team of researchers looking for ways to reduce or eliminate that problem recently conducted a study using larazotide acetate, a first-in-class oral peptide that prevents tight junction opening, and may reduce gluten uptake and associated problems.

The research team included C. P. Kelly, P. H. R. Green, J. A. Murray, A. DiMarino, A. Colatrella, D. A. Leffler, T. Alexander, R. Arsenescu, F. Leon, J. G. Jiang, L. A. Arterburner, B. M. Paterson, R. N. and Fedorak. They are affiliated with the Celiac Center of Beth Israel Deaconess Medical Center at Harvard Medical School in Boston, the Celiac Disease Center at Columbia University in New York, NY, the Division of Gastroenterology and Hepatology at the Mayo Clinic in Rochester, MN, Thomas Jefferson University Hospital in Philadelphia, PA, the Pittsburgh Gastroenterology Associates in Pittsburgh, PA, with Gastrointestinal Specialists of Troy, MI, the Department of Internal Medicine at the University of Kentucky, in Lexington, KY, with Alba Therapeutics Corporation in Baltimore, MD, and with the Division of Gastroenterology at the University of Alberta in Edmonton, AB.

The team wanted to find out how well larazotide acetate worked and how well it was tolerated by celiac disease patients undergoing a gluten challenge.

To do this, the team conducted an exploratory, double-blind, randomized, placebo-controlled study that included 184 patients who maintained a gluten-free diet before and during the study.

After a gluten-free diet run-in, the team randomly divided patients into groups and gave them either larazotide acetate in doses of 1, 4, or 8 mg three times daily, or a placebo. Both groups also received 2.7 grams of gluten daily for six weeks.

The team then assessed ratios of lactulose-to-mannitol (LAMA), an experimental biomarker of intestinal permeability, and measured clinical symptoms by Gastrointestinal Symptom Rating Scale (GSRS) and anti-transglutaminase antibody levels.

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They found no significant differences in LAMA ratios between larazotide acetate and placebo groups. Larazotide acetate 1-mg limited gluten-induced symptoms measured by GSRS (P = 0.002 vs. placebo).

They did find that the average ratio of anti-tissue transglutaminase IgA levels was 19.0 over baseline in the placebo group compared with 5.78 (P = 0.010) in the 1mg larazotide acetate group, 3.88 (P = 0.005) in the 4mg larazotide acetate group, and 7.72 (P = 0.025) in the 8mg larazotide acetate group.

Both the larazotide acetate and placebo groups showed similar rates of "adverse events."

Overall, the team found that larazotide acetate reduced gluten-induced immune reactivity and symptoms in celiac disease patients undergoing gluten challenge and was generally well tolerated.

However, the team found no significant difference in LAMA ratios between the larazotide acetate and placebo groups.

Even though they did not find anything revolutionary, the results and design of their study will likely be helpful in shaping future gluten-challenge studies in patients with celiac disease.

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2 Responses:

 
Turnip
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said this on
12 Feb 2013 2:48:17 PM PDT
I am glad someone has written something about this study. Many had high hopes for this. It was too good to be true. I have been following Dr. Fasano's papers and the last one in 2011 where he says that he believe that all autoimmunity is not auto perpetuating once you can remove the environmental triggers, stuff we swallow etc., then it can be stopped. I would suggest that Ketogenic diet and testing back paleo type carbs is the best we got unless you want to risk autoimmune suppressing drug alternatives which is a really really bad idea.

 
Lynne
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said this on
13 Feb 2013 8:31:49 AM PDT
I was diagnosed in 2006 and had been told at that time that this would likely be an option in a few years. Here we are 7 years later and we're still hearing "in a few years". So much for fast track status!!!




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I've given up on all those processed gluten free foods out there and have stuck to eating a whole foods diet. I have noticed such a huge, massive, difference in my energy, mood, sleep, and well being. Needless to say I've been doing a lot of cooking but have been leaving sugar out because I don't know the safe brands. I tried using Stevia in the raw but keep getting horrible headaches when I use it. I saw that the first ingredient is Dextrose so it's not "raw". Anyway, what are the safe brands out there as far as white and brown sugars go? I made saurkraut and pork chops last night and would've loved potato salad. Also while I'm on here, what about Mayo? What's safe? I saw Sir Kennsington was gluten-free Certified.

My Celiac disease presented as yours did: anemia, unexplained weight loss, aches and pains (due to vitamin and mineral deficiencies from malabsorption), the abdominal burning (whether I ate or not), decreased appetite, itching, the works. Plus I had a mood like a gorgon, which wasn't helped by my friends telling me "how slender!" I looked. My bones were basically all that was holding me up. I've had the blood panel too, which has proven very informative. I had a follow-up celiac panel after I'd been on the diet for over a year and it showed the diet was working. I also went through an anger phase because my (now former) doc (who is also my dad's doc and knows he has celiac AND knows we're related...) just wrote me a prescription for antidepressants, whereas I might have been spared years of feeling crappy (my late 30s!) if he'd just ordered a CBC and found the anemia. I'm a woman and I feel like sometimes whatever you say to a doc (even female docs!), all they hear is "psych symptoms". It really made me mad. But I've always pooped like a champ so I didn't exactly have typical symptoms either. Then I thought about how long it took my poor dad to get diagnosed (decades), which was before there was all this awareness, and I feel grateful for the fact that it took comparatively far less time for me to get my diagnosis and start feeling better. Don't worry about not finding stuff you like to eat: since gluten-free has become "the new thing" there are so many choices and the price has come down considerably since my dad got diagnosed (over 12 years ago). If your doc confirms celiac, then you'll be back on the (albeit gluten-free!) mac and cheese in no time, this time actually absorbing some of the mac and cheesy goodness! Feel better and take care.

If you are worried about your glycemic levels, then you should test with a glucose meter. I have diabetes (insulin resistance/TD2) and rice and potatoes spike me like crazy! I might as well consume ice cream! But if you do not have diabetes, no worries!

Thanks to both of you for your replies. I wasn't so much concerned about the arsenic (although that is an additional consideration) as I was about the glycemic level. I don't bake enough to make blending my own flour blends worthwhile, so I will definitely check out the links you provided, Ennis_TX. So far I'm tolerating oats and my gastro doc says I can keep eating them as long as they're certified GT. I just looked at some crackers I have for hummus and noticed their main ingredient is rice. I should probably just eat the hummus with veggies!

I agree with Ennis. It sounds like she is getting access to gluten way too often to expect healing. I had some pretty severe patches of intestinal damage when I was diagnosed. Anemia was my symptom and I had no gut issues then. So, just because she injests gluten and does not have some major symptoms right away, does not mean she is not building up antibodies. Have those antibodies been re-tested to see if they are in the normal ranges now? Missing patches of damage in the small intestine is possible. Heck, the small intestine is the size of a tennis court (goggle it). So easy to miss. Also, your GI should have taken more than four samples? How many were taken? (Forgive me, if I have forgotten.) Cross contamination in your house is real, especially if you have kids in the house. Member Jebby, a preemie doctor who has celiac disease, was not getting well. Turns out her four small and adorable children were glutening her. She made her house gluten free. Just something to consider. You mentioned she had access to gluten at a party. So, does that mean she caves in and eats it? She needs to become a stakeholder in this diet.