RecruitingNot ApplicableNCT06201182

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

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


Sponsor

Thammasat University

Enrollment

45 participants

Start Date

Aug 19, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Patients aged 18-70 years with IBS diagnosed by Rome IV criteria
  • Patients who can provide written informed consent.

Exclusion Criteria6

  • Pregnant or breastfeeding women
  • Severe comorbidities: chronic kidney disease (GFR<15 ml/min), cirrhosis, cancer, etc.
  • Fecal incontinence
  • Immunocompromised patients
  • Taking probiotic, or fermented food
  • Discontinue medication for IBS <1 month prior to study inclusion

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFMT via rectal enema

50 grams of FMT via rectal enema

DRUGFMT capsules

FMT capsules given twice daily for 2 consecutive days

DRUGPlacebo via rectal enema

Placebo via rectal enema

DRUGPlacebo capsules

Placebo capsules given twice daily for 2 consecutive days


Locations(1)

Thammasat University

Pathum Thani, Thailand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06201182


Related Trials