FMT in the Treatment of IBS (FMT-IBS)

Joint Authority for Päijät-Häme Social and Health Care

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Placebo; Other: Fecal Microbiota Transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03561519

40/13/03/01/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

FMT

Active Comparator group

Description:

IBS patients randomized to receive FMT from a healthy donor.

Treatment:

Other: Fecal Microbiota Transplantation (FMT)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo