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Recruiting NCT05432479

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

No phase Interventional Infantile Colic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic, Placebo.
Who it may be relevant to
Registry conditions: Infantile Colic. Basic parameters: 3 Weeks — 12 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • Dietary supplement Placebo
    Placebo

Primary outcome measures

  • Change in cry and fuss time [Time frame: Day 0 , Day 28]
Secondary outcome measures (4)
  • Resolution of colic symptoms [Time frame: Day 0, Day 28]
  • Change in cry and fuss time bouts [Time frame: Day 0, Day 28]
  • Change in sleeping time [Time frame: Day 0 Day 28]
  • Change in the use of rescue medications [Time frame: Day 0, Day 28]

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Atlantia Food Clinical Trials — Chicago
India · 1 center
  • Pulse Multispeciality Hospital, — Pune

Identifiers

NCT: NCT05432479 · PCTB202010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗