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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ADM Medical Team; Phone Number: +44 1460 243 230; Email: medical@protexin.com

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, Pune 411 041
      • Recruiting
      • Pulse Multispeciality Hospital,
      • Contact: Mr. Deepak Bagade; Phone Number: 9970004295; Email: dbagade66@gmail.com
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Completed
      • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 2 months (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Arm receiving placebo	Dietary supplement: Placebo; Placebo
Experimental: Active; Arm receiving investigation product (probiotic)	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cry and fuss time	eDiary parent reported cry and fuss time	Day 0 , Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of colic symptoms	Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline	Day 0, Day 28
Change in cry and fuss time bouts	eDiary parent reported cry and fuss bouts	Day 0, Day 28
Change in sleeping time	eDiary parent reported sleep time	Day 0 Day 28
Change in the use of rescue medications	Change in the proportion of participants needing to use rescue medications between the study arms	Day 0, Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maternal quality of life and mental health	Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score)	Day 0, Day 28
Change in maternal quality of life and mental health	Change in maternal QoL using MMPP/QoL (improvement marked by increase in the total score)	Day 0, Day 28

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Collaborators: Vedic Lifesciences Pvt. Ltd.; Atlantia Food Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: probiotic; Bifidobacterium; colic; cry
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: PCTB202010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No