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)
Change in cry and fuss time — Day 0 , Day 28 eDiary parent reported cry and fuss time
Trial sites (2)
Facility
City
Region
Status
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.
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