NCT06385054

Effect of Probiotics on Infantile Colic Symptoms

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 8 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2024-04-25
• Last updated: 2024-08-16

Locations

10 sites across 1 country: France