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

NCT05432479 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Infantile Colic

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

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Vedic Lifesciences Pvt. Ltd.

    collaborator INDUSTRY

  • The Archer-Daniels-Midland Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05432479 on ClinicalTrials.gov