A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

The Archer-Daniels-Midland Company2 sites in 2 countries80 target enrollmentSeptember 30, 2022

ConditionsInfantile Colic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infantile Colic
Sponsor: The Archer-Daniels-Midland Company
Enrollment: 80
Locations: 2
Primary Endpoint: Change in cry and fuss time
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 30, 2022

End Date

May 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Archer-Daniels-Midland Company

Responsible Party

Sponsor

Eligibility Criteria

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.