Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS): A Randomized, Placebo-controlled, Double-blind Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients aged 18-70 years with IBS diagnosed by Rome IV criteria

• Patients who can provide written informed consent.

Locations
Other Locations
Thailand
Thammasat University
RECRUITING
Pathum Thani
Contact Information
Primary
Natsuda Aumpan, MD
aumpan.natsuda@gmail.com
+66870494808
Backup
Ratha-korn Vilaichone, MD, PhD
vilaichone@hotmail.co.th
+66891044488
Time Frame
Start Date: 2020-08-19
Estimated Completion Date: 2024-08-19
Participants
Target number of participants: 45
Treatments
Experimental: FMT rectal enema
Patients will receive FMT via rectal enema and placebo capsules.
Experimental: Encapsulated FMT
Patients will receive FMT capsules and placebo via rectal enema.
Placebo_comparator: Placebo
Patients will receive placebo capsules and placebo via rectal enema.
Related Therapeutic Areas
Sponsors
Leads: Thammasat University

This content was sourced from clinicaltrials.gov