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Does New Drug Promise Cure for Celiac Disease?

Journal of Gluten Sensitivity Winter 2013 Issue


Image: CC--Jonathan Silverberg

Celiac.com 06/23/2017 - Dr. Alessio Fasano from the University of Maryland's Celiac Research Center published a paper in Clinical and Developmental Immunology last month. It focused on a new drug developed by Dr. Fasano that has shown promising results in both animal and human trials. But is this the 'magic pill' that will cure celiac disease and gluten sensitivity? Let's take a look.

The new drug, formerly called AT1001 but now renamed Larazotide Acetate, is a zonulin inhibitor. For those who have never heard the word 'zonulin', you might think it's a term from a science fiction movie. But zonulin is the protein that causes the 'gates' or openings between the cells making up the lining of the small intestine to open and close. These openings are called tight junctions and when zonulin gets excessive, a leaky gut ensues.

Dr. Fasano has made great inroads to prove that a leaky gut is a problem that must be handled with gluten intolerance. The leaky gut perpetuates gluten's negative impact on other parts of the body. It can also initiate autoimmune disease.

One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter.

So, the drug Larazotide Acetate is a zonulin inhibitor. Now that we've reviewed what zonulin does as regards opening the gates, the purpose of inhibiting its action should make sense. How well does it work? In the recent human trials that were double-blind, randomized placebo-controlled (the best type of study, but I would expect no less from the stellar Dr. Fasano), a gluten exposure created a 70% increase in intestinal permeability (leaky gut) in 57% of the placebo group but only 28.6% of the patients receiving the drug (4 out of 14 patients) experienced such increased permeability.

Further, gastrointestinal symptoms were significantly more frequent among patients of the placebo group as compared to the group that received the Larazotide.

A pro-inflammatory substance known as interferon gamma was also evaluated. This is manufactured by the body when a specific foreign/toxic agent is recognized by the body's immune system. As expected, levels of interferon gamma increased in 4 out of 7 of the placebo patients (57%) but only 4 out of 14 larazotide patients (28.6%) saw any increase.

The good news is that this drug seems well tolerated and it does reduce the leaky gut response that gluten ingestion normally creates. Further, it also reduces the percentage, by about half, of the production of interferon gamma. These are all excellent results.

But, and it's unfortunately a very big 'but', we have a very long way to go before such a drug would be useful for your typical celiac or gluten sensitive patient. Will Dr. Fasano and his team be able to tweak this drug such that it functions at a higher level of efficacy? I certainly hope so, but let's analyze exactly what this drug does in its present state:

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  • The drug still resulted in almost 30% of the patients experiencing a 70% increase in permeability (leaky gut) – Not good.

A highly pro-inflammatory (this means that it creates degenerative disease) substance known as interferon gamma was also produced in nearly 30% of the drug-consuming patients tested – Not good.

Leakiness, or the passage of negative substances through cells is not affected by this drug – Not good.
Of course on the plus side, over 70% of those tested DID have a very good result with apparently no untoward side effects – Very good.

At what point is the efficacy high enough that you'd be willing to subject yourself to a possible reaction? Do realize that any gluten ingested increases your chance of disease, chief amongst them cancer and autoimmune disease. Is there a level of function of the drug that you would chance taking it? Is it 90%, 99%? Does any drug ever get that good?

Well, as a big fan of Dr. Fasano's, I would say that if anyone can do it, he and his team can. But at the same time, I cannot help but think of all the other drugs I have encountered. As 'wonderful' as they sometimes seem initially, they almost always fall from grace when some horrible side effect is realized.

Would I guinea pig my own health that I've fought so hard to regain? Would I recommend taking such a chance to my children just so that they could consume some white flour product? I don't think so.

How about you? What do you think? If the drug were available right now at its efficacy of 71%, would you take it and hope you weren't in the 29% for whom it didn't work? I'd love to hear your thoughts.

If you are wondering if you're gluten intolerant or know that you are but still aren't enjoying good health, consider calling us for a free health analysis: 408-733-0400. We are here to help! Our destination clinic sees patients from across the country and internationally so you do not need to live locally to receive assistance.

To your good health!

Reference:

  • Alessio Fasano, Clinical and Developmental Immunology, Published online 2012 October 10. "Novel Therapeutic/Integrative Approaches for Celiac Disease and Dermatitis Herpetiformis."

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16 Responses:

 
Lori Gunter
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
26 Jun 2017 8:12:54 AM PDT
I was one that was in the clinical trial in Orange County, Ca. I am glad that someone is trying to help us with Celiac. I have been gluten free not for over 15 years and have seen big changes with doctors, restaurants and the public. I hope everyone takes celiac as serious as I do!!

 
Michael
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said this on
26 Jun 2017 11:51:02 AM PDT
There's no way I would try a drug with 30% ineffectiveness. There's no way I would allow a "vaccine" with gluten peptides to be injected, and the one reported on last month had a 30% adverse event rate: that means increased autoimmunity. In my education and experience, in regards to help for celiac patients, the drug companies are never going to equal medical cannabis, which protects the brain, modifies B-cell and T-cell activity, helps the immune system to recognize self, and upregulates occludin, which counters zonulin. Not only that, cannabis stops the growth of cancer in five different ways, including helping the immune system recognize cancer cells as non-self.

 
Keith MacFarland
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said this on
26 Jun 2017 1:35:05 PM PDT
Great article (as always, you write beautifully) but I've seen no real movement on any drug or cure for the past 8 years. It's as if we are just "stuck" at phase 2b or less on all solutions and at the speed of this research I will long be dead before I will ever see a cure or substance that allows me to eat gluten safely again. When my twins who are celiac are out on their own I will likely go off my diet.. quality of life is nil when I'm forced to eat at the same restaurants and eat the same food all the time..

 
Marie
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said this on
26 Jun 2017 5:10:38 PM PDT
I think this drug is good for any other disease where cell permeability is involved, other than celiac. I still believe genetic manipulation is the only way to cure celiac disease.

 
Adair hallman
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said this on
26 Jun 2017 7:22:47 PM PDT
My husband has severe celiac and my son he was eight and has almost died twice. The better part of a leaky got my husband, and he is beginning to have bipolar symptoms...please we would love to try the Zonulin!

 
Chris M
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said this on
26 Jun 2017 7:58:41 PM PDT
I'm excited, especially for the ones who suffer terribly when ingesting gluten. I myself was diagnosed with celiac disease 15 years ago, although if I have a half of a roll once or twice a year or drink a Corona Light occasionally I never have any reactions. Not sure why. Nothing ever seems to bother me but I still continue to do quite a good job staying away from gluten. This article gives me hope that I may be able some day to enjoy the food I love again.

 
Tara
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said this on
28 Jun 2017 9:08:14 AM PDT
There are celiacs that are asymptomatic but their insides show the damage. My uncle is like this and does the same. My friends husband died because of lymphoma caused by celiac. Be safe and if you eat the odd roll and carona get your gut checked every year.

 
Daniel S
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said this on
26 Jun 2017 10:26:25 PM PDT
70% is good, mainly for people that have issues with Gluten but are non celiac, how long to hit the shelves?

 
Laura
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said this on
27 Jun 2017 3:29:40 AM PDT
Answer to would I try it: NO! I have been devastated by celiac disease and associated food toxicities. 2009 was the year when the public first heart about the gluten protein. Chronic & severe diarrhea following meals was too elusive for a certain diagnosis. A gastroenterologist publicized the relationship between celiac and its cross-mediators/cross-reactors: yeast, dairy, egg and coffee. Additionally, symptomology occurred with: preservatives and artificial flavoring. Through trial & error, I discovered other foodstuffs that create a toxic effect: flower and seed oils. Research of the oil extraction processed revealed that extreme heat and chemicals creates toxins. This too contributed to the GI effect. Long term & repeated exposures resulted in malnutrition and neurological disturbances to the point of Near Death by Gluten. Hybridization of wheat has occurred since the 1950’s. Chemical analysis revealed the gluten ratio has increased by 17 times since 1960. Six slices of today’s wheat bread have the gluten equivalent of 102 slices of the 1960’s version. There is no reversal of this disease. This disease effects hundreds of thousands of people and it DID NOT HAVE TO HAPPEN! Is it any surprise that GI cancer has increased substantially in the US?

 
Pat
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said this on
27 Jun 2017 4:22:19 AM PDT
Very good information, but I too would not risk the chance of gluten exposure. The diet is not hard, so why would I?

 
Janice Messer
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said this on
27 Jun 2017 5:21:52 AM PDT
I was diagnosed with non tropical Sprue (Celiac disease) over 43 years ago. I would not take the pill and see no need to. There are so many opportunities now to eat gluten free. Yes, I have had times when I didn't know gluten was in something, but those times are now fewer and less drastic, thank God.

 
L Maureen
Rating: ratingfullratingemptyratingemptyratingemptyratingempty Unrated
said this on
27 Jun 2017 6:51:26 AM PDT
I can't even finish this article, because the writing is so terrible. I can't understand what the author is trying to say. For instance, this passage makes no sense: "One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter."

 
Olena
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said this on
28 Jun 2017 10:50:01 AM PDT
That's what I thought!

 
David Quig, PhD
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said this on
27 Jun 2017 7:52:09 AM PDT
I'm not sure why you focus so much on the lack of effect of the compound on transcellular transport- very important for water/electrolyte balance as well as the uptake of other small molecules...why would one want to mess with that? I too very much appreciate Dr. Fasano's work and enthusiasm, but do agree that 70% efficacy doesn't cut it and strict avoidance is pretty much the only sure way to go (coming from a former senior pharmacologists).

 
Dunnyveg
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said this on
01 Jul 2017 7:57:14 AM PDT
This is one drug I'd like to be able to take, even if I were never to eat gluten. I've noticed that even walking by the bakery in grocery stores, or even at times the bread section, it's enough to give me a headache. Also, I live around wheat fields. Since farmers aren't going to quit growing wheat to keep me happy, I can only hope and pray this drugs works, and becomes available at a price that won't make cocaine and heroin dealers envious.

 
Laura
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said this on
01 Jul 2017 9:41:41 AM PDT
When I was a little girl in the 1950's, I'd grocery shop with my mother. When we traveled down the bread isles we would stop to smell the sweet odor of the baked breads. Over the last 7 years I have to cover my nose and mouth while moving rapidly down to the end of the isle. What a strong STENCH! The breads REEK, so FOUL smelling!




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