NCT05432479

Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Archer-Daniels-Midland Company · Industry
• Sex: All
• Age: 3 Weeks – 12 Weeks
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Single strain probiotic in a form of a sachets with a daily dose of 1.0E+9 Colony Forming Unit (CFU) per day for 4 weeks
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2022-09-30
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-06-27
• Last updated: 2025-04-09

Locations

2 sites across 2 countries: United States, India