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Effect of Probiotics on Infantile Colic Symptoms

NCT06385054 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-16

No results posted yet for this study

Summary

The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.

Conditions

  • Infantile Colic

Interventions

DIETARY_SUPPLEMENT

Probiotic

Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.

DIETARY_SUPPLEMENT

Placebo

Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • Lallemand Health Solutions

    lead INDUSTRY

Principal Investigators

  • Pr. Nicholas Kalach, MD · Groupement des Hôpitaux de l'Institut Catholique de Lille

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-02-28
Completion
2027-02-28

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 NCT06385054 on ClinicalTrials.gov