Efficacy of Bacillus clausii in Childhood Constipation: A Randomized, Double-Blind, Placebo Controlled Trial

Phase 2

• Conditions: Functional constipation age 1-5 years; constipation, children, probiotics.

• Registration Number: TCTR202103110010
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-11
• Study Completion: 2023-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Children age 1-5 years with constipation according to ROME IV criteria at Ramathibodi hospital

Exclusion Criteria

Organic causes of constipation, receive medication causing constipation,
immune deficiency, severe neurological or cardiac anomalies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Good stooling 4 weeks Bristol stool scale, frequency of stools

Secondary Outcome Measures

Name	Time	Method
se of enema 4 weeks Times used