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Reply to P Collin et al

Center for Celiac Research
20 Penn Street
University of Maryland School of Medicine
Baltimore, MD 21201
E-mail: afasano{at}mbrc.umaryland.edu

Dear Sir:

We sincerely appreciate the comments from Collin et al and agree with most of the issues raised. Indeed, ours was the first randomized controlled double-blind study that was aimed at settling a long discussion among experts in the field on a safe threshold of traces of gluten allowable for celiac disease patients (1). Given the complexity of the study design, we had to limit our microchallenge doses to 10 and 50 mg gluten/d. Therefore, we surely agree that information regarding intermediate amounts of gluten are lacking. Nevertheless, the fact that 10 mg gluten/d appeared safe for most of the subjects studied, whereas 50 mg/d induced histologic changes after 3 mo of exposure, allowed us to conclude that 20 ppm would be the safest and most conservative threshold to recommend for gluten-free products. Given the regional differences in daily wheat substitute intakes, this threshold would be applicable worldwide rather than being customized to local lifestyle realities. The fact that the circulation of gluten-free products is now beyond national boundaries requires guidelines as widely applicable as possible. We agree that too strict limits, as advocated by some celiac support leaders (2), may lead to the limited availability of gluten-free products and an increase in production costs. However, it is our understanding that the current costs, availability, and palatability of wheat substitutes in countries where 20 ppm is the accepted threshold are not different from those of products sold in northern Europe, where 200 ppm is the recommended daily gluten intake. Therefore, we see no advantage to embracing gluten limits that may harm those populations that consume higher amounts of wheat substitutes than the Finnish population (3). The fact that the Food and Drug Administration recently defined gluten-free products as those products that contain <20 ppm gluten (4) is testimony to the validity and feasibility of this threshold. This has been a noteworthy accomplishment, as testified by national newspaper editorials, including the Wall Street Journal (2). To conclude, although we agree that the findings of our pilot study should be confirmed by clinical trials in a larger number of subjects, the findings of our study will contribute to the improvement in the quality of life of celiac disease patients and their families.

ACKNOWLEDGMENTS

AF has economic interests in Alba Therapeutics, a company that conducts research on the treatment of autoimmune diseases, including type 1 diabetes and celiac disease. CC serves as a consultant for Biaglut and Schär, companies that produce gluten-free products.

REFERENCES

1. Catassi C, Fabiani E, Iacono G, et al. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr 2007;85:160–6.[Abstract/Free Full Text]
2. Zhang J. FDA calls for standards on gluten. Wall Street Journal 2007 Jan 23:page D3.
3. Gibert A, Espadaler M, Angel Canela M, Sanchez A, Vaque C, Rafecas M. Consumption of gluten-free products: should the threshold value for trace amounts of gluten be at 20, 100 or 200 p.p.m.? Eur J Gastroenterol Hepatol 2006;18:1187–95.[Medline]
4. US Department of Health and Human Services, Food and Drug Administration.. Food labeling; gluten-free labeling of foods. Fed Reg 2007;72(14):21 CFR Part 101.

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