RecruitingPhase 2NCT06385054

Effect of Probiotics on Infantile Colic Symptoms

Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).


Sponsor

Lallemand Health Solutions

Enrollment

70 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 8 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and Probiotic for people with infantile colic. The study is currently recruiting participants at 10 locations. People eligible for this study include up to age 8 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotic

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

DIETARY_SUPPLEMENTPlacebo

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


Locations(10)

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

View Full Details on ClinicalTrials.gov

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NCT06385054


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