Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Infantile Colic
In brief
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.
Key facts
- Study ID
- NCT05432479
- Run by
- The Archer-Daniels-Midland Company
- People needed
- 80
- Starts
- 2022-09-30
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-04-09
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Pulse Multispeciality Hospital, — Pune, Maharashtra, India (enrolling)
- Atlantia Food Clinical Trials — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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