Exploratory, randomized, double-blind, placebo-controlled trial on the effects of orally administered Bifidobacterium infantis in untreated celiac disease

EDGARDO SMECUOL; HWANG WJ; CHERÑAVSKY A; VÁZQUEZ H; CORSO L; SUGAI E; BELLAVITE P; MORENO ML; MAZURE R; VODÁNOVICH F; NIVELONI S; LOZANO G; MEDDINGS J; GONZÁLEZ A; MAURIÑO E; BAI JC

Congreso; Digestive Disease Week; 2012

American Society of Gasstroenterology

Background: The probiotic bacteria Bifidobacterium, which has been shown to be deficient in the intestinal microbiome of CD patients, has demonstrated to exert anti-inflammatory and immune-modulating properties in models of CD. Objective: We aimed to explore the effect of Bifidobacterium infantis orally administered for 3 weeks on clinical features, intestinal permeability, serology, inflammatory and immunologic parameters in patients having serological evidences of untreated CD. Patients: Fifty-four adult patients suspected of CD were screened at the time that a positive CD serology strongly suggested the disorder (two concomitantly positives tests were required). Twenty-two patients (18 female) fulfilled inclusion criteria and were enrolled in the study. Biopsy at the end of the trial confirmed CD in all cases. Methods: This is a 3-week randomized, double blind, placebo controlled trial administrating two capsules of B. infantis NLS super strain (Natren Lifestart 2®) (2 x 109 colony-forming units per capsule) or placebo T.I.D. 15 minutes before meals. The study period lapsed between the serologic diagnosis and the duodenal biopsy while patients consumed a gluten containing diet (at least 12 gr of gluten/day) weekly assessed by expert dietitians. Clinical symptoms (GSRS questionnaire), lactulose/mannitol permeability, IgA tissue transglutaminase and DGP antibody serum concentrations and blood sampling for peripheral blood mononuclear cell release of the cytokines IL-10 and IL-12p40 were assessed at baseline and at the end of the trial. Results: Twelve and ten patients were randomized to B. infantis or placebo, respectively. Contrasting with the placebo arm, patients randomized to B. infantis experienced a greater improvement of scores of GSRS (p=0.0035 for indigestion, p=0.0483 for constipation and p=0.0586 for reflux syndromes). The trend of scores was not statistically significant for diarrhea and abdominal pain syndromes. Compared with placebo, final/baseline IgA tTG and IgA DGP antibody concentration ratios had a greater decrease in the B. infantis arm (p=0.055 for IgA tTG and p=0.181 for IgA DGP). No significant differences were found in intestinal permeability to lactulose/mannitol and IL-10/IL-12p40 (p=0.226) ratios. Overall, B. infantis was found to be safe and all patients completed the study without adverse events. Conclusion: The present study is the first to explore the effect of B. infantis in untreated CD. Our results suggest a positive effect of the probiotic improving symptom scores and serum concentrations of IgA tTG antibody compared with placebo. We were not able to detect significant changes in the immunologic profile and in intestinal permeability. The study also suggests that administration of B. infantis for CD seems to be safe. Further studies are needed to confirm our findings.