Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS): A Randomized, placebo-controlled, double-blind study

Phase 2

Recruiting

• Conditions: irritable bowel syndrome; fecal microbiota transplantation; treatment outcome; quality of life

• Registration Number: TCTR20230904002
• Lead Sponsor: Thammasat university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Study Completion: 2024-08-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Patients with irritable bowel syndrome defined by the Rome IV criteria

Exclusion Criteria

1. pregnancy, 2. breastfeeding, 3. fecal incontinence, 4. severe comorbidities (end-stage renal disease, Child-Pugh class C cirrhosis, acquired immunodeficiency syndrome, cancer, cerebrovascular disease, cardiovascular disease), 5. immunodeficiency disorders, 6. use of immunosuppressive drugs, 7. use of probiotics within 4 weeks prior to study entry, 8. use of IBS medication within 4 weeks prior to study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response 4 weeks after FMT IBS-symptom severity score (IBS-SSS)

Secondary Outcome Measures

Name	Time	Method
Quality of life 4 weeks after FMT IBS quality of life score,Microbial diversity 4 weeks after FMT 16S amplicon community profiling