Role of Probiotics on growth and diarrhea in childre

Phase 3

Completed

• Registration Number: CTRI/2012/08/002942
• Lead Sponsor: Danisco Finland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

children aged 3-5 years, Parents willing to add a probiotic supplement or placebo each day for 10 months will be included in the study.

Exclusion Criteria

Children with major congenital birth deformities, acute illness at enrollment, or chronic conditions affecting food intake or metabolism, Participation in another clinical study, Infants from multiple gestation births (since only one child per family will be included in the study, incorporating a child from a multiple birth would add unnecessary burden to parents by requiring them to administer different formulas to different children), past history with surgical operation of gastrointestinal tracts, Antibiotic therapy prior to enrollment, Evidence or suspicion of clinical sepsis before randomization will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified