Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial
Elena Lionetti, Simona Gatti, Tiziana Galeazzi, Nicole Caporelli, Ruggiero Francavilla, Salvatore Cucchiara, Paola Roggero, Basilio Malamisura, Giuseppe Iacono, Stefania Tomarchio, Wolfgang Kleon, Patrizia Restani, Ignazio Brusca, Andrea Budelli, Rosaria Gesuita, Flavia Carle, Carlo Catassi, Elena Lionetti, Simona Gatti, Tiziana Galeazzi, Nicole Caporelli, Ruggiero Francavilla, Salvatore Cucchiara, Paola Roggero, Basilio Malamisura, Giuseppe Iacono, Stefania Tomarchio, Wolfgang Kleon, Patrizia Restani, Ignazio Brusca, Andrea Budelli, Rosaria Gesuita, Flavia Carle, Carlo Catassi
Abstract
Objective: To evaluate the long-term validity and safety of pure oats in the treatment of children with celiac disease.
Study design: This noninferiority clinical trial used a double-blind, placebo-controlled, crossover design extended over 15 months. Three hundred six children with a biopsy-proven diagnosis of celiac disease on a gluten-free diet for ≥2 years were randomly assigned to eat specifically prepared gluten-free food containing an age-dependent amount (15-40 g) of either placebo or purified nonreactive varieties of oats for 2 consecutive 6-month periods separated by washout standard gluten-free diet for 3 months. Clinical (body mass index, Gastrointestinal Symptoms Rating Scale score), serologic (IgA antitransglutaminase antibodies, and IgA anti-avenin antibodies), and intestinal permeability data were measured at baseline, and after 6, 9, and 15 months. Direct treatment effect was evaluated by a nonparametric approach using medians (95% CI) as summary statistic.
Results: After the exclusion of 129 patients who dropped out, the cohort included 177 children (79 in the oats-placebo and 98 in the placebo-oats group; median, 0.004; 95% CI, -0.0002 to 0.0089). Direct treatment effect was not statistically significant for clinical, serologic, and intestinal permeability variables (body mass index: median, -0.5; 95% CI, -0.12 to 0.00; Gastrointestinal Symptoms Rating Scale score: median, 0; 95% CI, -2.5 to 0.00; IgA antitransglutaminase antibodies: median, -0.02; 95% CI, -0.25 to 0.23; IgA anti-avenin antibodies: median, -0.0002; 95% CI, -0.0007 to 0.0003; intestinal permeability test: median, 0.004; 95% CI, -0.0002 to 0.0089).
Conclusions: Pure nonreactive oat products are a safe dietary choice in the treatment of children with celiac disease.
Trial registration: ClinicalTrials.gov: NCT00808301.
Keywords: Celiac disease; children; gluten-free diet; oats; safety; toxicity.
Copyright © 2017 Elsevier Inc. All rights reserved.
Source: PubMed