Status:
RECRUITING
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Lead Sponsor:
The Archer-Daniels-Midland Company
Collaborating Sponsors:
Atlantia Food Clinical Trials
Vedic Lifesciences Pvt. Ltd.
Conditions:
Infantile Colic
Eligibility:
All Genders
3-12 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05432479
Start Date
September 30 2022
End Date
May 1 2026
Last Update
April 9 2025
Active Locations (2)
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1
Atlantia Food Clinical Trials
Chicago, Illinois, United States, 60611
2
Pulse Multispeciality Hospital,
Pune, Maharashtra, India, Pune 411 041