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RECRUITINGNA

Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

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

NCT05432479•The Archer-Daniels-Midland Company

View on ClinicalTrials.gov

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

0 - 0 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (2)

Atlantia Food Clinical Trials

Chicago, Illinois, United States

Pulse Multispeciality Hospital,

Pune, Maharashtra, India

Key Dates

Start Date

September 30, 2022

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

April 9, 2025

Enrollment

ESTIMATED participants

Conditions

Infantile Colic

Interventions

Probiotic

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Contacts

ADM Medical Team

CONTACT

+44 1460 243 230 medical@protexin.com

Effect of Probiotics on Infantile Colic Symptoms

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COMPLETEDPHASE2

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

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COMPLETEDNA

The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

Inclusion Criteria

Exclusion Criteria

Effect of Probiotics on Infantile Colic Symptoms

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy

Probiotics After Discharge

Lactobacillus Reuteri for the Treatment of Infantile Colic: