Original articleAlimentary tractSmall Amounts of Gluten in Subjects With Suspected Nonceliac Gluten Sensitivity: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial
Section snippets
Study Design and Population
The study was a prospective, randomized, placebo-controlled, cross-over trial that compared the effects of a daily dose of 4.375 g gluten with placebo in patients strongly suspected of having NCGS. The patients and the physicians who administered the interventions were blinded. Enrollment started in September 2012, and follow-up evaluation was completed in January 2014. The Ethics Committee at both clinical sites (Pavia and Bologna) approved the study (trial registration number: ISRCTN72857280;
Results
According to the cross-over trial design, 31 patients (arm 1) started with gluten capsules in the first treatment week (W1–W2), followed by placebo capsules in the second week (W3–W4), whereas 30 patients (arm 2) started with placebo capsules in the first treatment week, followed by gluten capsules in the second week (Figure 2). Baseline characteristics were similar between the groups (Table 1). Fifty-nine of the 61 randomized patients completed the 5-week trial as per protocol, 2 patients
Discussion
Gluten proteins are among the most complex protein systems owing to numerous components of various sizes, and owing to further variability determined by genotype, growing conditions, and technologic processes.17 The complexity of the gluten structure couples with the multifaceted pathologic and clinical spectrum of gluten-related conditions that, in addition to celiac disease,18 include wheat allergy and a number of extraintestinal disorders.19 Moreover, gluten administration for long periods
Acknowledgments
The authors thank Dr Antonio Colantoni for statistical contributions, Dr Mara De Amici (St. Matteo Hospital Foundation, Pavia, Italy) for technical advice on enzyme-linked immunosorbent assay tests, and Professor Elide A. Pastorello (Niguarda Ca' Granda Hospital, Milan, Italy) for scientific advice on wheat allergy. The authors also thank the St. Matteo Hospital Foundation (Pavia, Italy) for supporting the study, and Giuliani Pharma (Milan, Italy) for providing the capsules.
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Conflicts of interest The authors disclose no conflicts.