NCT05198700

The Effect of Probiotics on Symptoms of Infantile Colic

The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 8 Weeks
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.

Detailed description

Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm 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 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.

Conditions

• Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Formulation	Participants will be asked to take one sachet daily, containing 1 billion CFU of the probiotic formula. Sachets must be dissolved in warm water or mother's milk before consumption.
DIETARY_SUPPLEMENT	Placebo	Participants will be asked to take one sachet containing the placebo daily. Sachets must be dissolved in warm water or mother's milk before consumption.

Timeline

• Start date: 2022-02-08
• Primary completion: 2023-09-01
• Completion: 2024-02-01
• First posted: 2022-01-20
• Last updated: 2023-07-03

Locations

5 sites across 1 country: Spain