Safe Gluten Threshold Study

[ENF]

Wondering what people think of this new report about a "safe gluten threshold", which was in the latest Celiac.com Update (and this site).

Research Study on the Establishment of a Safe Gluten Threshold for Celiac Disease Patients

Celiac.com 01/10/2007

Celiac disease researchers in Italy and at the Center For Celiac Research in Baltimore, Maryland have conducted a multi center, double-blind, placebo-controlled, randomized trial involving 49 adult individuals who have biopsy-proven celiac disease, and who have been on a gluten-free diet that contains less than 5mg of gluten per day for a minimum of two years

[Ursa Major]

This is my take on this study.

First of all, 49 people is a rather small sampling. Some got capsules with 0 mg gluten, and if some actually took 50 mg a day, they must have sort of staggered how much people took. If some only got 0 gluten, there were less than 49 people getting gluten. Some tiny amounts, some more.

One person who got 10 mg of gluten a day had a relapse. I imagine that means that he got quite ill, and his villi were obviously damaged.

One out of 49 people getting really sick again, some of whom didn't get any gluten is really HIGH! They don't say if others felt as well as they did before this study. They probably only looked at levels in the blood, and villi damage. What about neurological damage, or depression? Was that taken into consideration?

I understand that some people appear to not have any reaction of any kind to minute amounts of gluten. Good for them (and I think I am actually one of those people). But there are also people who are so sensitive that they get violently ill with the tiniest amount of gluten.

I say in order to have me convinced that up to 50 mg a day is okay, they'd have to do a much larger study (involving at least 1000 people, not 49), and include some people who get very sick from just one crumb. And report on what the symptoms were that people suffered, including brain fog, heart palpitations, dizziness, depression etc.

Mind you, I agree that being too paranoid can ruin your life, and is detrimental to your mental health. But to draw the conclusion that up to 50 mg a day of gluten is okay from such a tiny study is, in my opinion, irresponsible and misleading.

[Nancym]

Those numbers sounds weird... I know that gluten flour is 40-80% gluten. Most flours are around 15% gluten. I know sometimes they add extra gluten to bread to make the dough stiffer. So what does a slice of bread weigh? Lets say 56 grams, about 2 ounces. So 15% of 56 is 8.4 grams, unless I'm messing up somehow.

Open Original Shared Link

Oh wait, I should have read the study first. 50mg... I was thinking in terms of grams.

If you divide 4,800 by 50 it equals 96, so if divide an ordinary slice of bread into 96 pieces, that is roughly how much daily gluten, according to this study, appears to be safe for those with celiac disease.

Right so 1/100th piece of bread every day. That's a pretty danged teeny amount.

I wonder how long they ran this study? They don't mention it. It might take months or years to have that sort of damage show up in most people. Besides, there more to this gluten stuff than blood tests and biopsies reveal.

[happygirl]

Nancy:

This is the official abstract of the journal article, which gives you a brief overview of "how" the study was run:

prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease.Catassi C, Fabiani E, Iacono G, D'Agate C, Francavilla R, Biagi F, Volta U, Accomando S, Picarelli A, De Vitis I, Pianelli G, Gesuita R, Carle F, Mandolesi A, Bearzi I, Fasano A.

Center For Celiac Research, University of Maryland School of Medicine, Baltimore, MD.

BACKGROUND: Treatment of celiac disease (celiac disease) is based on the avoidance of gluten-containing food. However, it is not known whether trace amounts of gluten are harmful to treated patients. OBJECTIVE: The objective was to establish the safety threshold of prolonged exposure to trace amounts of gluten (ie, contaminating gluten). DESIGN: This was a multicenter, double-blind, placebo-controlled, randomized trial in 49 adults with biopsy-proven celiac disease who were being treated with a gluten-free diet (GFD) for >/=2 y. The background daily gluten intake was maintained at <5 mg. After a baseline evaluation (t(0)), patients were assigned to ingest daily for 90 d a capsule containing 0, 10, or 50 mg gluten. Clinical, serologic, and histologic evaluations of the small intestine were performed at t(0) and after the gluten microchallenge (t(1)). RESULTS: At t(0), the median villous height/crypt depth (Vh/celiac disease) in the small-intestinal mucosa was significantly lower and the intraepithelial lymphocyte (IEL) count (x 100 enterocytes) significantly higher in the celiac disease patients (Vh/celiac disease: 2.20; 95% CI: 2.11, 2.89; IEL: 27; 95% CI: 23, 34) than in 20 non-celiac disease control subjects (Vh/celiac disease: 2.87; 95% CI: 2.50, 3.09; IEL: 22; 95% CI: 18, 24). One patient (challenged with 10 mg gluten) developed a clinical relapse. At t(1), the percentage change in Vh/celiac disease was 9% (95% CI: 3%, 15%) in the placebo group (n = 13), -1% (-18%, 68%) in the 10-mg group (n = 13), and -20% (-22%, -13%) in the 50-mg group (n = 13). No significant differences in the IEL count were found between the 3 groups. CONCLUSIONS: The ingestion of contaminating gluten should be kept lower than 50 mg/d in the treatment of celiac disease.

OFF TOPIC:

*this is only a guess, but I think its a pretty good one. The same authors recruited participants for the zonulin/drug that closes the tight junctions, hence stopping the pathway for gluten to cross into an area, preventing the autoimmune reaction. My guess is that these were participants in the trial but were those who did NOT receive the drug, and yet still ingested gluten (they would not have known if they had a placebo or the AT-1001 drug). The structure of this study is very similar to the overall zonulin trial. I never saw this being advertised as a separate study, so this is probably a *smaller* part of their larger research goals.