RECRUITING

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

Conditions

Infantile Colic probiotic Bifidobacterium colic cry

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-30

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05432479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Weeks to 12 Weeks

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

ADM Medical Team

CONTACT

+44 1460 243 230

medical@protexin.com

Study Locations (Sites)

Atlantia Food Clinical Trials

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: The Archer-Daniels-Midland Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-30

Study Completion Date2026-05

Study Record Updates

Study Start Date2022-09-30

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

probiotic
Bifidobacterium
colic
cry

Additional Relevant MeSH Terms

Infantile Colic