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.

Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial / Lionetti, E.; Gatti, S.; Galeazzi, T.; Caporelli, N.; Francavilla, R.; Cucchiara, S.; Roggero, P.; Malamisura, B.; Iacono, G.; Tomarchio, S.; Kleon, W.; Restani, P.; Brusca, I.; Budelli, A.; Gesuita, R.; Carle, F.; Catassi, C.. - In: THE JOURNAL OF PEDIATRICS. - ISSN 0022-3476. - 194:(2018), pp. 116-122.e2. [10.1016/j.jpeds.2017.10.062]

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

Lionetti E.;Gatti S.;Galeazzi T.;Caporelli N.;Francavilla R.;Cucchiara S.;Roggero P.;Gesuita R.;Carle F.;Catassi C.
2018-01-01

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.
2018
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11566/294914
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