NCT05432479

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

June 21, 2022

Last Update Submit

April 8, 2025

Conditions

Infantile Colic

Keywords

probioticBifidobacteriumcoliccry

Outcome Measures

Primary Outcomes (1)

  • Change in cry and fuss time

    eDiary parent reported cry and fuss time

    Day 0 , Day 28

Secondary Outcomes (4)

  • Resolution of colic symptoms

    Day 0, Day 28

  • Change in cry and fuss time bouts

    Day 0, Day 28

  • Change in sleeping time

    Day 0 Day 28

  • Change in the use of rescue medications

    Day 0, Day 28

Other Outcomes (2)

  • Change in maternal quality of life and mental health

    Day 0, Day 28

  • Change in maternal quality of life and mental health

    Day 0, Day 28

Study Arms (2)

Active

EXPERIMENTAL

Arm receiving investigation product (probiotic)

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Arm receiving placebo

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

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

Active
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age3 Weeks - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atlantia Food Clinical Trials

Chicago, Illinois, 60611, United States

COMPLETED

Pulse Multispeciality Hospital,

Pune, Maharashtra, Pune 411 041, India

RECRUITING

MeSH Terms

Conditions

ColicCrying

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

ADM Medical Team

CONTACT

+44 1460 243 230medical@protexin.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

September 30, 2022

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)IN(1)