FMT in the Treatment of IBS (FMT-IBS)

August 14, 2018 updated by: Joint Authority for Päijät-Häme Social and Health Care

FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME

52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • 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 Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital

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

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of IBS based on Rome III criteria
  • Having received traditional treatment for at least 1 month
  • Availability of consecutive fecal samples over one year.
  • Compliance to attend ileocolonoscopy and FMT procedure.
  • 18-75 years

Exclusion Criteria:

  • Unable to provide informed consent
  • Antibiotic therapy in past 3 months
  • Inflammatory bowel disease (IBD)

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FMT
IBS patients randomized to receive FMT from a healthy donor.
Other: Fecal Microbiota Transplantation (FMT)
Fecal suspension administered in colonoscopy into the cecum of the patient.
Placebo Comparator: Placebo
IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo.
Other: Placebo
As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS symptom relieve
Time Frame: 52 weeks
Reduction IBS-SSS by 50 points, The irritable bowel severity score system in which the maximum achievable score is 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.( Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.)
52 weeks

Collaborators and Investigators

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

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Collaborators

Helsinki University Central Hospital
University of Helsinki

Investigators

  • Study Chair: Perttu Arkkila, Adj. Prof., +358 9 4711

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)

August 27, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 17, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40/13/03/01/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared.

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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