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A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease^1,2,3

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.

Key Words: Gastroenterology • celiac disease • gluten toxicity • small-intestinal morphometry • gluten-free diet • gluten threshold in gluten-free food

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