Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial. (REFIT)

University Hospital of North Norway

Status and phase

Completed

Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Other: Placebo fecal transplant

Biological: Fecal transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02154867

2013/971/REK

Details and patient eligibility

About

Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial - the REFIT project

Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of life and increased sickness absence. The prevalence of IBS in the general population may be as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other less well founded theories have been stated. So far, no measurement or test can affirm diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern according to the Rome classification can set the diagnosis.

Earlier non-controlled case reports have shown a convincing effect of fecal microbial transplantation (FMT) in IBS patients. However, no placebo controlled trial has been performed in this condition. Changes in the gut microbiome may be an important factor in IBS pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may trigger changes in visceral sensibility and pain perception.

The fecal microbial transplantation (FMT) procedure has been used primarily to treat clostridium difficile infections. Few minor side effects have been reported.

Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by transplanting a microbiome sample from a healthy donor.

Aim of study:

To test the clinical effect of FMT in patients with IBS
To describe the fecal microbiome in IBS patients
To describe changes in the fecal microbiome of IBS patients following FMT

The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients will recruited from general practice and allocated to active (30) or placebo (30) by block randomization. Donors will be 15 healthy volunteers with no risk behaviour and a pre-screening for communicable diseases will be performed.

Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0, 1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.

Enrollment

90 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for patients:

Patients with IBS-D according to Roma 3 criteria

Exclusion Criteria for patients:

Immunomodulating medication
Nocturnal abdominal pain
Constant abdominal pain
Alarm symptoms like rectal bleeding, weight loss, nightsweats
Symptomatic heart/vascular/lung disease
Renal failure
Known food allergy
Microscopic/collagenous colitis
non-compliant
BMI <18

Inclusion criteria for donors:

healthy volunteers

Exclusion criteria for donors

Tattoos, imprisoning or piercing last 3 months
Any history of chronic diarrhoea, constipation, inflammatory bowel disease, irritable bowel disease, colorectal polyps or cancer, immunosuppression, morbid obesity, metabolic syndrome, atopica, or fatigue
positive test for hepatitis B, C, HIV, treponema pallidum
sexual high risk habits
antibiotic treatment in the past 3 months