Codex, 20ppm? 200ppm ?

[gfp]

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QUOTE ("Establishing a gluten threshold in celiac disease

Nutrition Research Newsletter @ Feb, 2007 ")

Celiac disease (celiac disease) is an immune-mediated enteropathy triggered by the ingestion of gluten--the major protein fraction contained in the cereals wheat, rye, and barley--in genetically susceptible persons. The standard treatment of celiac disease involves the consumption of a diet completely devoid of gluten proteins, a so-called gluten-free diet (GFD). However, it is almost impossible to maintain a diet with a zero gluten content because gluten contamination is very common in food. Even products specifically targeted to dietary treatment of celiac disease may contain trace amounts of gluten protein, either because of the cross-contamination of originally gluten-free cereals during their milling, storage, and manipulation or because of the presence of wheat starch as a major ingredient.

The potential toxicity of trace amounts of gluten is still unclear. Establishing a safe threshold of gluten consumption for celiac disease patients is a matter of major public health importance, particularly in light of the recent reports concerning the high prevalence of the disease worldwide.

A prospective, double-blind, placebo-controlled multicenter trial to investigate the toxicity of gluten traces in the celiac diet was performed. Subjects included adults with biopsy-proven celiac disease who had consumed a GFD for 2 years and who were in apparent good health.

The patients qualifying for the trial underwent a screening and a dietary interview (t--1). They were asked (1) to maintain a strict GFD during the study period.

After 1 month the subjects returned for a baseline evaluation (to) which involved

1) a clinical examination,

2) a dietary interview,

3) blood collection for serum anti-tTG antibody and anti-gliadin antibody (AGA) measurements, and

4) an endoscopy and small-intestinal biopsy.

While still adhering to a strict GFD, the patients were randomly assigned to ingest daily and for 90 days a capsule containing either 10 mg purified gluten, 50 mg purified gluten, or 50 mg cornstarch as a placebo. After completing the 3-month challenge (t--1), the patients repeated the same clinical, serologic, and histologic tests as at (to).

At (to) 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, 24) than in 20 non-celiac disease control subjects (Vh/celiac disease: 2.87; 95% CI: 25.0, 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 three groups.

It is concluded that the ingestion of contaminating gluten should be kept lower than 50 mg/d in the treatment of celiac disease. C. Catssi, E. Fabiani, G Iacono, et al. A Prospective, Double-Blind, Placebo-Controlled Trial to Establish a Safe Gluten Threshold for Patients with Celiac Disease. Am J Clin Nutr; 85:160-166 (January 2007). [Correspondence: A. Fasano, Mucosal Biology Research Center, University of Maryland School of Medicine, 20 Penn STree, Room 345, Baltimore, MD 21201. E-mail: afasano@mbrc.umaryland.edu.]

notes:

40 people in Total ... 1 had relapse pre-trial on 10mg/day. 1:40 is not a tiny amount... 1:40 is far more than the incidence of celiac disease in the general population!

The respondents were ASKED to keep to a GFD.... no testing of their intake or strictness is given.

The Vh/celiac disease was different for the control, 10mg and 50 mg groups.. indeed if this is a element of how seriously the villi are damaged then ... the control was +9% whereas the 10mg/d was -1% and 50mg/d -20%

This really begs the question .... HOW gluten-free were the diets before the test ???

Is it possible that of 40 people only 1 person was on a 100% strict gluten-free diet?

Once again noone MEASURED what these people were eating....

I will take the same test results:

The conclusion is that no significant changes occured in 34 subjects fed small amounts of gluten daily YET the control group showed a positive increase in Vh/Vc ...

Further one test subject reacted immediately to the 10mg.

Conclusion: Most diagnosed celaics are not properly informed or able to keep to a 100% gluten-free diet.

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Besides the above problem with the test cases being 100% gluten-free to start with:

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“It is a historical misconception,” says Dr Tom O’Bryan that “gluten sensitivity is regarded as a disease of the small intestine.” It is not widely known that gluten-related symptoms and conditions can affect any organ system.

The National Institutes of Health (NIH) issued a consensus statement that Celiac disease is significantly under-diagnosed and may affect 3 million Americans (1 percent of the population); however, another estimated 5 percent have gluten intolerance.

The NIH panel called for greater physician and public awareness and earlier testing.

The following is only a partial list of symptoms and conditions associated with celiac disease/GI that warrant celiac testing:

[Rya]

If anybody is basing anything on a study with 40 people, they need their heads checked. My hope is that this study is going to be a jumping point for much research to come. Maybe next test they'll use a more reliable measure than villi testing - so many feet of intestine, how do you know where the worst damage is? Everything I've read says stool testing is better...what do you guys think?

[gfp]

If anybody is basing anything on a study with 40 people, they need their heads checked. My hope is that this study is going to be a jumping point for much research to come. Maybe next test they'll use a more reliable measure than villi testing - so many feet of intestine, how do you know where the worst damage is? Everything I've read says stool testing is better...what do you guys think?

What worries me most about this is the 'baseline'.

The damage seen with 10mg/d seems totally acceptable because it is accepted that everyone in the test is 'as gluten free as they can be'.

I really strongly suspect they only had 1 single person in the whole group who was gluten-free before the tests and this is the person who had the relapse.

I also find it disturbing that one person in forty suffering clinical relapse it is acceptable. What annoys me most are the 'old timers' who campaigned when incidence was 1:5000 for the 'right to gluten-free food', the people that fought those who sais impossible for 1 person in 5000.

Now we are looking at 1:40 celiacs in an incidence of 1:150. (1:2000 of general population) and apparently its fine for these people to be clinically too ill to do a trial and to guarantee SAFE food for them. This is hypocrisy at its worse.

This is the freed slave buying slaves, the persecuted minority persecuting a smaller minority. These people are worse than the general ignorant public because they are not ignorant, they just choose to be selfish.

Every study I manage to SEE says the damage was 'not worse than'.... I just fail to see how this is acceptable.

[Tim-n-VA]

40 people in Total ... 1 had relapse pre-trial on 10mg/day. 1:40 is not a tiny amount... 1:40 is far more than the incidence of celiac disease in the general population!

Not sure point that you intended here but I'm a little concerned that someone might read it as 1 in 40 people react to an amount as little as 10mg/day. Remember that the people in the study are biopsy confirmed celiacs so that would be only 1 in 40 of celiacs or 1 in 5320 of the general population (using 1 in 133 as the rate for celiac).

Also, the bottom line is that we don't know how successfully the subjects were at following a GFD. Probably just a successfully as any celiac trying to follow the diet. Maybe the one who reacted to the small amount was one of those who ate a lot of gluten on the side. We don't know.

Any study has weaknesses, this one seemed to state its test conditions. It appears to be a better study than taking a few statistics out of context, guessing about the diet of the subject and reaching another conclusion.

[gfp]

Not sure point that you intended here but I'm a little concerned that someone might read it as 1 in 40 people react to an amount as little as 10mg/day. Remember that the people in the study are biopsy confirmed celiacs so that would be only 1 in 40 of celiacs or 1 in 5320 of the general population (using 1 in 133 as the rate for celiac).

Actually that is EXACTLY my point....

10 years ago 1:5000 was considered the incidence for celiac disease.

Now today we are saying that if 1:5320 people react to small amounts of gluten that is OK ?

However its not saying 1:40 react... indeed they don't provide those stats....

Of the 26 people eating gluten most of them reacted ... since they don't state EXACTLY what the percentiles are I can't back-out the figures.

Of the 13 eating 10mg/d the 'average' (by which I'm assuming mean) had NEGATIVE villi growth.

Either one was so bad they skewed the results to -9% or some didn't react...

Also, the bottom line is that we don't know how successfully the subjects were at following a GFD. Probably just a successfully as any celiac trying to follow the diet. Maybe the one who reacted to the small amount was one of those who ate a lot of gluten on the side. We don't know.

Any study has weaknesses, this one seemed to state its test conditions. It appears to be a better study than taking a few statistics out of context, guessing about the diet of the subject and reaching another conclusion.

Again I absolutely agree.... (with the first part)... we have no idea nor have the study how well they followed the GFD either before or during the trial.

When we are testing 10mg/d then environmental factors must be considered.

Any study has weaknesses

True but Alba just received a cash injection of $135 million. 40 people does not seem very large.

Subjects included adults with biopsy-proven celiac disease who had consumed a GFD for 2 years and who were in apparent good health.

Read carefully.... it say's included... not comprised.

As someone who has written quite a few biased scientific studies in my time... I find it worrying.

Fasano has access to thousands of subjects he has all the lab work for.

He has patient histories and data not used i the studies. (He has genetics for instance)

Nothing in this study tells me he didn't pick specific haplotypes for the study.

He also has a vested interest in a 1 Billion $ per year product specifically for allowing celiacs to eat trace amounts of gluten.

Hypothetically as an adviser to the FDA if the limit for gluten-free is set at an amount that will make people sick unless they take the pill Alba seem ready to see that 1 Billion market expand.

Overall, I just don't see how the results FIT the presented data. How does an 'average' -1% in villi growth seem positive? Did those on the placebo not do better ???