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FMT in the Treatment of IBS (FMT-IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation (FMT)
Placebo
Sponsored by
Joint Authority for Päijät-Häme Social and Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

FMT

Placebo

Arm Description

IBS patients randomized to receive FMT from a healthy donor.

IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo.

Outcomes

Primary Outcome Measures

IBS symptom relieve
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.)

Secondary Outcome Measures

Full Information

First Posted
June 6, 2018
Last Updated
August 14, 2018
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Helsinki University Central Hospital, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT03561519
Brief Title
FMT in the Treatment of IBS
Acronym
FMT-IBS
Official Title
FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 27, 2015 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Helsinki University Central Hospital, University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization was done by personnel not treating the patient. The participant or FMT providing personnel did not know the result of randomization. The doctors assessing the outcome have been blinded of the result of randomization.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT
Arm Type
Active Comparator
Arm Description
IBS patients randomized to receive FMT from a healthy donor.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo.
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation (FMT)
Intervention Description
Fecal suspension administered in colonoscopy into the cecum of the patient.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.
Primary Outcome Measure Information:
Title
IBS symptom relieve
Description
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.)
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perttu Arkkila, Adj. Prof.
Organizational Affiliation
+358 9 4711
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.
Citations:
PubMed Identifier
32343000
Citation
Lahtinen P, Jalanka J, Hartikainen A, Mattila E, Hillila M, Punkkinen J, Koskenpato J, Anttila VJ, Tillonen J, Satokari R, Arkkila P. Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome. Aliment Pharmacol Ther. 2020 Jun;51(12):1321-1331. doi: 10.1111/apt.15740. Epub 2020 Apr 28.
Results Reference
derived

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FMT in the Treatment of IBS

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