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Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

NCT01887444 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time \>50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.

Conditions

  • Infantile Colic

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM17938 probiotic

Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion.

OTHER

Placebo

Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.

Sponsors & Collaborators

  • CRC CHI Creteil France

    collaborator OTHER_GOV

  • Association Clinique Thérapeutique Infantile du val de Marne

    collaborator OTHER

  • Hopital Universitaire Robert-Debre

    collaborator OTHER

  • BioGaia AB

    lead INDUSTRY

Principal Investigators

  • Marc Bellaiche, MD · Hopital Universitaire Robert-Debre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-05-31
Completion
2014-09-30

Countries

  • France

Study Locations

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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 NCT01887444 on ClinicalTrials.gov