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aklap
Joined: 02 Oct 2004
Posts: 8136
Location: WI, USA
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 Posted: Sat Jan 06, 2007 10:06 am Post subject: Safe gluten threshold for patients with CD (Jan 07) |
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http://www.ajcn.org/cgi/content/abstract/85/1/160
| Quote: | ORIGINAL RESEARCH COMMUNICATION
A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease1,2,3
Carlo Catassi, Elisabetta Fabiani, Giuseppe Iacono, Cinzia D'Agate, Ruggiero Francavilla, Federico Biagi, Umberto Volta, Salvatore Accomando, Antonio Picarelli, Italo De Vitis, Giovanna Pianelli, Rosaria Gesuita, Flavia Carle, Alessandra Mandolesi, Italo Bearzi and Alessio Fasano
1 From the Center For Celiac Research, University of Maryland School of Medicine, Baltimore, MD (CC and AF); the Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy (CC, EF, and GP); the Department of Gastroenterology, Children Hospital, Palermo, Italy (GI); the University Department of Gastroenterology, Catania, Italy (CD); the University Department of Pediatrics, Bari, Italy (RF); the University Department of Gastroenterology, Pavia, Italy (FB); the University Department of Internal Medicine, Bologna, Italy (UV); the University Department of Pediatrics, Palermo, Italy (SA); the Department of Gastroenterology, "La Sapienza" University, Rome, Italy (AP); the Gastroenterology Unit, Catholic University of Sacred Heart, Rome, Italy (ID); the Department of Biostatistics, Università Politecnica delle Marche, Ancona, Italy (RG and FC); the Department of Pathology, Università Politecnica delle Marche, Ancona, Italy (AM and IB)
Background: Treatment of celiac disease (CD) 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 CD 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 (t0), 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 t0 and after the gluten microchallenge (t1).
Results: At t0, the median villous height/crypt depth (Vh/Cd) in the small-intestinal mucosa was significantly lower and the intraepithelial lymphocyte (IEL) count (x 100 enterocytes) significantly higher in the CD patients (Vh/Cd: 2.20; 95% CI: 2.11, 2.89; IEL: 27; 95% CI: 23, 34) than in 20 non-CD control subjects (Vh/Cd: 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 t1, the percentage change in Vh/Cd 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 CD. |
Thanks Anne for finding this!
EDIT: 3/21/07
I found the full text study on this
http://www.celiaccenter.org/celiac/documents/catassi%20et%20al%20AJCN%202007.pdf
This explains how and why the 20ppm was chosen:
| Quote: | Currently, different national positions hamper the implementation
of uniform guidelines on the maximum level of gluten
contamination (expressed as ppm) that can be tolerated in products
that are marketed for the treatment of CD. This is a “hot”
topic that was recently reviewed extensively (28, 29). In Northern
European countries, up to 200ppmgluten is permitted in food
for CD patients, to use wheat starch as ingredient. Conversely, a
more prudent value of 20 ppm has been adopted in North American
and southern European countries. On the basis of their clinical
and analytic data, Finnish experts recently advocated the
intermediate limit of 100 ppm (30). The decision about what the
threshold is depends, however, not only on the minimum toxic
dose but also on the amount of gluten-free products consumed.
Our results indicate that 200 ppm is not a safe threshold because
the harmful gluten intake of 50 mg/d could be reached even with
a moderate consumption ( 250 g/d) of nominally gluten-free
products. A 100-ppm threshold, by allowing up to 10 mg gluten/
100 g product, is also probably not suitable for generalized use,
especially in countries such as Italy, where consumption of wheat
substitutes is occasionally as high as 500 g/d (as shown by our
data). The threshold of 20 ppm keeps the intake of gluten from
“special celiac food” well below the amount of 50 mg/d, which
allows a safety margin for the variable gluten sensitivity and
dietary habits of patients. |
_________________
Al
“We cannot all do great things, but we can do small things with great love.” Mother Teresa
Last edited by aklap on Wed Mar 21, 2007 10:27 pm; edited 2 times in total |
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Fidissimus
Joined: 17 Mar 2006
Posts: 1455
Location: Portland, OR.
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| Posted: Sat Jan 06, 2007 12:35 pm Post subject: |
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Is there a publish date and source for this article?
_________________
Cheers!
Jenn
GF BD: Feb. 2001
Free of wheat, barley, rye, oats, rice, dairy, eggs, almonds, pineapple and brewers yeast.
http://graindamaged.blogspot.com/ |
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aklap
Joined: 02 Oct 2004
Posts: 8136
Location: WI, USA
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| Posted: Sat Jan 06, 2007 12:36 pm Post subject: |
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I have asked Anne about it...she has not responded to me yet  Anne has access to all sorts medical stuff due to her profession. I did a quick google and could not find this article...but I didnt look too hard either.
_________________
Al
“We cannot all do great things, but we can do small things with great love.” Mother Teresa |
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Fidissimus
Joined: 17 Mar 2006
Posts: 1455
Location: Portland, OR.
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| Posted: Sat Jan 06, 2007 2:53 pm Post subject: |
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Thanks for checking into it - it seems very relevant and I'd like to put it in our newsletter but would want to site it properly. 
_________________
Cheers!
Jenn
GF BD: Feb. 2001
Free of wheat, barley, rye, oats, rice, dairy, eggs, almonds, pineapple and brewers yeast.
http://graindamaged.blogspot.com/ |
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maryjk
Joined: 28 Nov 2006
Posts: 71
Location: Auburn Alabama
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| Posted: Sat Jan 06, 2007 2:55 pm Post subject: |
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| Fidissimus wrote: | | Is there a publish date and source for this article? |
American Journal of Clinical Nutrition, January 2007
| Quote: | | (These articles have been accepted for this issue. Change is possible before publication.) |
I know nothing about the article, just found this information on line. I am sometimes called the Google Queen.  |
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aklap
Joined: 02 Oct 2004
Posts: 8136
Location: WI, USA
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| Posted: Sat Jan 06, 2007 3:06 pm Post subject: |
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Yup - here's the abstract:
http://www.ajcn.org/cgi/content/abstract/85/1/160
Thanks Nancy!!!
_________________
Al
“We cannot all do great things, but we can do small things with great love.” Mother Teresa |
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John
Joined: 12 Oct 2006
Posts: 70
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| Posted: Wed Jan 10, 2007 8:29 am Post subject: |
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Am I reading that wrong or aren't they saying that there's a 10% difference in villae height between the placebo and the 10 mg gluten group? And that one person had a total relapse at that dosage?
Yet they say <50 is safe? This does not encourage me  |
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aklap
Joined: 02 Oct 2004
Posts: 8136
Location: WI, USA
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| Posted: Wed Mar 21, 2007 10:28 pm Post subject: |
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To add the full text of this study
_________________
Al
“We cannot all do great things, but we can do small things with great love.” Mother Teresa |
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