Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial

The Journal of Pediatrics
Elena LionettiCarlo Catassi

Abstract

To evaluate the long-term validity and safety of pure oats in the treatment of children with celiac disease. 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. 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 intestina...Continue Reading

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Citations

Oct 5, 2019·Nutrients·Iva HoffmanováHelena Tlaskalová-Hogenová
Sep 27, 2019·Frontiers in Pediatrics·Alina Popp, Markku Mäki
Mar 7, 2020·Plant Foods for Human Nutrition·Klára KosováVáclav Dvořáček
Nov 12, 2020·Expert Review of Gastroenterology & Hepatology·Alma KurkiKatri Lindfors
Jan 19, 2020·Journal of the Academy of Nutrition and Dietetics·Feon W Cheng, Deepa Handu
Apr 29, 2021·Journal of Pediatric Gastroenterology and Nutrition·Siba Prosad PaulPeter Michael Gillett
Sep 7, 2021·The Journal of Nutrition·Ezra ValidoMarija Glisic
Oct 19, 2021·Frontiers in Nutrition·Gyöngyvér GellFerenc Békés

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