FMT in the Treatment of IBS

NCT03561519 | Completed

• 1 other identifier: 40/13/03/01/15
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

FMT

ACTIVE COMPARATOR

IBS patients randomized to receive FMT from a healthy donor.

Other: Fecal Microbiota Transplantation (FMT)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Fecal Microbiota Transplantation (FMT) OTHER

Fecal suspension administered in colonoscopy into the cecum of the patient.

FMT

Placebo OTHER

As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years

You may not qualify if:

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

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead
• Helsinki University Central Hospital: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Related Publications (1)

• 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.

  PMID: 32343000 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Perttu Arkkila, Adj. Prof.

  +358 9 4711

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 19, 2018
• Study Start: August 27, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)