A Randomized, Double-Blind, Crossover, Placebo Controlled Trial of Bacillus clausii in Childhood Constipatio

Phase 4

• Conditions: - Constipation; Bacillus clausii; Stool frequency; Stool consistency

• Registration Number: TCTR20200222003
• Lead Sponsor: &#45

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-22
• Study Completion: 2021-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Children who was diagnosed constipation by ROME IV criteria.

Exclusion Criteria

Children with suspected or proven organic causes of constipation, use medication causing constipation, receive antibiotic during study, immunocompromised host, neurological impairment and congenital heart disease were excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stool frequency and consistency 8 week after start protocol stool chart

Secondary Outcome Measures

Name	Time	Method
abdominal pain, fecal incontinence, painful defecation 8 week after start protocol Patient reported outcome using a questionnaire interview