A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
The Archer-Daniels-Midland Company
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
- Age range
- 0–0 years
- Sex
- All
- 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. * Pa…
Interventions
- Dietary SupplementProbiotic
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 SupplementPlacebo
Placebo
Locations (2)
- Atlantia Food Clinical TrialsChicago, Illinois
- Pulse Multispeciality Hospital,Pune, Maharashtra