Effect of L. Reuteri on Bowel Movements in Children (BIOWELL Study)

Completed 52 enrolled Centre Hospitalier Intercommunal Creteil BioGaia AB · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.

Timeline

Start: 2017-03-01
Primary completion: 2021-06-30
Completion: 2021-07-30

Outcome

Missed primary endpoint

paper This double-blind randomized controlled trial did not confirm the efficacy of L. reuteri for treatment of chronic functional constipation in young children. PMID 36389355 ↗

Publications

Jung C, Kalach N, Degas V, Jeridi Y, Bertrand V, Bellaiche M. Effect of L. reuteri on bowel movements in children aged 6 months to 4 years: A double-blind randomized controlled trial. Front Pediatr. 2022 Oct 26;10:997104. doi: 10.3389/fped.2022.997104. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lactobacillus reuteri	Other / unclassified	1e+08 unknown	Oral