Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial - 23/02/18
, Simona Gatti, MD 1, Tiziana Galeazzi, PhD 1, Nicole Caporelli, MD 1, Ruggiero Francavilla, PhD 2, Salvatore Cucchiara, MPH 3, Paola Roggero, MD 4, Basilio Malamisura, MD 5, Giuseppe Iacono, MD 6, Stefania Tomarchio, MD 7, Wolfgang Kleon, MD 8, Patrizia Restani, PhD 9, Ignazio Brusca, MD 10, Andrea Budelli, PhD 11, Rosaria Gesuita, MPH 12, Flavia Carle, MPH 12, Carlo Catassi, MPH 1Abstract |
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.
Le texte complet de cet article est disponible en PDF.Keywords : Celiac disease, children, gluten-free diet, oats, safety, toxicity
Abbreviations : AB, BA, AGA, ELISA, GFD, GSRS, IPT, L/M, TGA2
Plan
| Partially funded by Heinz Italia S.p.A, Latina, Italy. A.B. works for Heinz Italia S.p.A. E.L. and C.C. served as a consultant for Dr Schär SPA. The other authors declare no conflicts of interest. |
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| Portions of this study were presented at the 49th Annual Meeting of the European Society of Paediatric Gastroenterology (ESPGHAN), May 25-28, 2016, Athens, Greece, and at the World Congress of Paediatric Gastroenterology, Hepatology and Nutrition (WCPGHAN), October 5-8, 2016, Montréal, Canada. |
Vol 194
P. 116 - mars 2018 Retour au numéro
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