Probiotics in the Management of Functional Constipation in Childre

Phase 3

Recruiting

• Conditions: Functional Constipation.; Constipation; K59.0

• Registration Number: IRCT20231004059611N1
• Lead Sponsor: Bandare-abbas University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Children aged 2 to 12 years
Having functional constipation based on Rome criteria 4
Not using probiotics, prebiotics or antibiotics 4 weeks before the start of the research
No history of gastrointestinal surgery
Lack of sensitivity or tolerance to Lactobacillus roteri (Reuteflor)
Interest in participating in the study and consent of family/guardian

Exclusion Criteria

Children with organic digestive disorders or any other underlying disease that can affect bowel function.
Children with mental disability
Current use of medications that affect bowel function such as laxatives or antidiarrheals
History of using probiotics, prebiotics or antibiotics 4 weeks before the start of the research
Inability or unwillingness to comply with the study protocol or follow-up
History of participating in a different clinical trial in the last 3 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Constipation based on ROME IV Criteria. Timepoint: Initial Presentation and Subsequent Observations on Days 7, 14, 21, and 28, as well as Two Months Post-Administration of Probiotics. Method of measurement: ROME IV Criteria.