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NCT03561519 Clinical Trial

FMT in the Treatment of IBS

Irritable Bowel Syndrome Clinical Trial

— FMT-IBS  

Official title:
FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03561519
Other study ID # 40/13/03/01/15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 27, 2015
Est. completion date July 1, 2018

Study information
Verified date June 2018
Source Joint Authority for Päijät-Häme Social and Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Fecal Microbiota Transplantation (FMT)
Fecal suspension administered in colonoscopy into the cecum of the patient.
• Placebo
As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.

Locations
Country Name City State
Finland Helsinki University Hospital Helsinki

Sponsors (3)
Lead Sponsor Collaborator
Joint Authority for Päijät-Häme Social and Health Care Helsinki University, Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.) 52 weeks
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