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

April 12, 2024 updated by: Natsuda Aumpan, MD, Thammasat University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Irritable bowel syndrome (IBS) is a common functional bowel disorder defined by recurrent abdominal pain related to defecation or a change in bowel habit (1). Pathogenic mechanisms of IBS include gut microbial dysbiosis, low-grade mucosal inflammation, increased gut permeability, and altered gut-brain interaction (2). Dysbiosis is an imbalance of gut microbiota which can contribute to IBS. Emerging treatment approach for IBS aims to correct dysbiosis by modulation of intestinal microbiota (3).

Fecal microbiota transplantation (FMT) is an administration of feces from a healthy donor to the gastrointestinal tract of a recipient in order to restore balanced microbial flora (4). Correcting gut dysbiosis might be another target to improve IBS symptoms. Some previous randomized controlled trials demonstrated that FMT could provide clinical response in patients with IBS (5-7), whereas others reported no different outcome from placebo (8, 9). Most trials delivered FMT via more invasive routes such as colonoscopy or gastroscopy. There were few studies using less invasive methods, e.g., oral FMT capsules and FMT via rectal enema. Less invasive routes of FMT administration are needed to be evaluated so as to reduce risk and cost of endoscopy.

This study aimed to determine efficacy of FMT via rectal enema and encapsulated FMT compared with placebo in IBS patients in Thailand.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FMT rectal enema
Patients will receive FMT via rectal enema and placebo capsules.
Drug: FMT via rectal enema
50 grams of FMT via rectal enema
Drug: Placebo capsules
Placebo capsules given twice daily for 2 consecutive days
Experimental: Encapsulated FMT
Patients will receive FMT capsules and placebo via rectal enema.
Drug: FMT capsules
FMT capsules given twice daily for 2 consecutive days
Drug: Placebo via rectal enema
Placebo via rectal enema
Placebo Comparator: Placebo
Patients will receive placebo capsules and placebo via rectal enema.
Drug: Placebo capsules
Placebo capsules given twice daily for 2 consecutive days
Drug: Placebo via rectal enema
Placebo via rectal enema

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of responders
Time Frame: 4 weeks, 12 weeks
Response is defined as a decrease in IBS-symptom severity score (IBS-SSS) more than 50 points from baseline.
4 weeks, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: 4 weeks, 12 weeks
Record adverse events during and after treatment
4 weeks, 12 weeks
Changes in microbiota diversity before and after FMT
Time Frame: 4 weeks
Evaluate changes in microbiota diversity before and after FMT
4 weeks
Quality of life score
Time Frame: 4 weeks, 12 weeks
Quality of life score will be assessed in both FMT and placebo groups
4 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MTU-EC-IM-1-080/63

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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