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

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230904002
Enrollment
45
Registered
2023-09-04
Start date
2020-08-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irritable bowel syndrome irritable bowel syndrome fecal microbiota transplantation treatment outcome quality of life

Interventions

Patients in this arm will receive encapsulated FMT (6 capsules twice daily for two consecutive days) and placebo via rectal enema,Patients in this arm will receive FMT via rectal enema (50 grams of st
Encapsulated FMT,FMT rectal enema,Placebo

Sponsors

Thammasat university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with irritable bowel syndrome defined by the Rome IV criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Clinical response 4 weeks after FMT IBS-symptom severity score (IBS-SSS)

Secondary

MeasureTime frame
Quality of life 4 weeks after FMT IBS quality of life score,Microbial diversity 4 weeks after FMT 16S amplicon community profiling

Countries

Thailand

Contacts

Public ContactNatsuda Aumpan

Chulabhorn International College of Medicine (CICM) at Thammasat University

aumpan.natsuda@gmail.com0870494808

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026