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Clinical Trials in India / NCT05432479
Recruiting

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

NCT05432479 · tracked via the Priya Life Science India tracker
Sponsor
The Archer-Daniels-Midland Company
Phase
N/A
Started
2022-09-30
Last updated
2025-04-09

Condition(s) studied

Infantile Colic

Investigational drug(s) / intervention(s)

ProbioticPlacebo

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

Placebo: Placebo

Study 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.

Eligibility

Sex
ALL
Min age
3 Weeks
Max age
12 Weeks
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Atlantia Food Clinical Trials Chicago Illinois Completed
Pulse Multispeciality Hospital, Pune Maharashtra Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05432479 on ClinicalTrials.gov ↗ ← All trials in India