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

NCT03030664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-06-13

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

L.reuteri

Each day, at about the same time, the subjects will be given 5 drops (1x10\^8 CFU) of the study product in connection with feeding

DRUG

Placebo

Same formulation as study product, without probiotics.

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Centre Hospitalier Intercommunal Creteil

    lead OTHER

Principal Investigators

  • Marc BELLAICHE, MD · Hopital Universitaire Robert-Debre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03030664 on ClinicalTrials.gov