Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study

Simona Gatti, Nicole Caporelli, Tiziana Galeazzi, Ruggiero Francavilla, Maria Barbato, Paola Roggero, Basilio Malamisura, Giuseppe Iacono, Andrea Budelli, Rosaria Gesuita, Carlo Catassi, Elena Lionetti, Simona Gatti, Nicole Caporelli, Tiziana Galeazzi, Ruggiero Francavilla, Maria Barbato, Paola Roggero, Basilio Malamisura, Giuseppe Iacono, Andrea Budelli, Rosaria Gesuita, Carlo Catassi, Elena Lionetti

Abstract

A gluten-free diet (GFD) is currently the only available treatment for patients with celiac disease (CD). Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet "A", 3 months of standard GFD, 6 months of diet "B"), or B-A treatment (6 months of diet "B", 3 months of standard GFD, 6 months of diet "A"). A and B diets included gluten-free (GF) products (flour, pasta, biscuits, cakes and crisp toasts) with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score) and intestinal permeability tests (IPT), were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M) ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms.

Figures

Figure 1
Figure 1
Flow-chart of the multicenter trial (t0: baseline, t3: 3-month follow-up, t6: 6-month follow-up, t9: 9-month follow-up, t12: 12-month follow-up, t15: 15-month follow-up; GSRS: Gastrointestinal Symptoms Rate Scale, IgA tTG: IgA class anti-transglutaminase antibody, IgG DGP: IgG class deamidated gliadin peptides antibody).
Figure 2
Figure 2
GSRS score in group A and B at enrollment and after 6 months (median and IQR): in both groups a significant reduction in GI symptoms was observed.
Figure 3
Figure 3
Change in GSRS score (∆-GSRS score, median and IQR) between t6 and t0 in the 2 groups.
Figure 4
Figure 4
Urinary L/M ratio in group A and B at t0 and t6 (median, IQR): in both groups no significant difference was observed after 6 months of treatment.
Figure 5
Figure 5
Comparison between t6 and t0 urinary L/M values in groups A and B (∆ t6-t0, median and IQR).
Figure 6
Figure 6
Changes in L/M values (median, IQR) according to the 3 age classes, in groups A and B, respectively.

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