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Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS)

NCT06201182 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-04-15

No results posted yet for this study

Summary

The goal of this clinical trial is to determine efficacy of FMT via rectal enema and encapsulated FMT in patients with IBS in Thailand. The main question it aims to answer is:

• Does FMT provide better efficacy than placebo in IBS patients?

Participants will be randomized into 3 groups:

* In placebo group, patients will receive placebo capsules and placebo via enema.
* In enema group, patients will receive placebo capsules and FMT via rectal enema.
* In capsule group, patients will receive FMT capsules and placebo via rectal enema.

Researchers will compare FMT and placebo group to see if using FMT provides better efficacy for IBS patients than placebo. Moreover, researchers will compare efficacy of FMT capsules and FMT via rectal enema in IBS patients.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

FMT via rectal enema

50 grams of FMT via rectal enema

DRUG

FMT capsules

FMT capsules given twice daily for 2 consecutive days

DRUG

Placebo via rectal enema

Placebo via rectal enema

DRUG

Placebo capsules

Placebo capsules given twice daily for 2 consecutive days

Sponsors & Collaborators

  • Thammasat University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2024-08-19
Completion
2024-08-19

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06201182 on ClinicalTrials.gov