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Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).
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.
The goal of this clinical trial is to evaluate the potential beneficial effects of B. lactis B94 on the symptoms of infantile colic. Participants diagnosed with infantile colic will be recruited to participate in this randomized, double-blind, placebo controlled, two-armed parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period. The study will consist of 3 in-person visits and 4 phone calls.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Cabinet privé Dr Regimbart-Trubuil Christine
Bécon-les-Granits, France
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, France
CHU Caen Normandie
Caen, France
CHU Grenoble Alpes
La Tronche, France
Hôpital Saint Vincent de Paul
Lille, France
Centre Hospitalier de Montauban
Montauban, France
CHU de NANTES
Nantes, France
Biofortis, Unité d'investigation Clinique
Paris, France
Biofortis, Unité d'investigation Clinique
Saint-Herblain, France
Centre Hospitalier du val d'Ariège
Saint-Jean-de-Verges, France
Start Date
August 1, 2024
Primary Completion Date
February 1, 2026
Completion Date
February 1, 2027
Last Updated
August 16, 2024
70
ESTIMATED participants
Probiotic
DIETARY_SUPPLEMENT
Placebo
DIETARY_SUPPLEMENT
Lead Sponsor
Lallemand Health Solutions
Collaborators
NCT05432479
NCT04487834
NCT04632888
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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