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

Not Applicable

Recruiting

• Conditions: Infantile Colic
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT05432479
• Lead Sponsor: The Archer-Daniels-Midland Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-27
• Study Start: 2022-09-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Gestational age of minimum 37 weeks.
• Birthweight of minimum 2500 g (5.5 lb.).
• Age of greater than 3 weeks and less than 12 weeks at enrolment.
• Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording >3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period & for duration of study).
• Participant Informed Consent form signed by parent or legal guardian.
• Infant is considered healthy following physical exam.
• Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits

Exclusion Criteria

• Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
• Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
• Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
• Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
• Failure to thrive.
• Known lactose or gluten intolerance.
• Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.
• Known other causes for abdominal pain (e.g., pyloric stenosis).
• Participation in any other interventional clinical study.
• Immuno-compromised participant or participant with other severe chronic disorder.
• Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.
• Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.
• Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Arm receiving placebo
Active	Probiotic	Arm receiving investigation product (probiotic)

Primary Outcome Measures

Name	Time	Method
Change in cry and fuss time	Day 0 , Day 28	eDiary parent reported cry and fuss time

Secondary Outcome Measures

Name	Time	Method
Change in cry and fuss time bouts	Day 0, Day 28	eDiary parent reported cry and fuss bouts
Change in the use of rescue medications	Day 0, Day 28	Change in the proportion of participants needing to use rescue medications between the study arms
Resolution of colic symptoms	Day 0, Day 28	Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
Change in sleeping time	Day 0 Day 28	eDiary parent reported sleep time

Trial Locations

Locations (2)

Atlantia Food Clinical Trials; 🇺🇸 Chicago, Illinois, United States

Pulse Multispeciality Hospital,; 🇮🇳 Pune, Maharashtra, India