This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments fecal transplantation, placebo fecal transplant
Phase phase 2
Sponsor University Hospital of North Norway
Start date December 2014
End date September 2016
Trial size 60 participants
Trial identifier NCT02154867, 2013/971/REK


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Fecal transplantation of freshly prepared feces from healthy donor. Application by colonoscope in proximal half of colon.
fecal transplantation Fecal microbial transplantation
Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.
(Placebo Comparator)
Sham transplant subject's own feces. Application by colonoscope in proximal part of colon.
placebo fecal transplant
Fecal transplantation with own feces

Primary Outcomes

Change in subjective symptom score
time frame: at 0 and 3 months

Secondary Outcomes

Microbiome profile change
time frame: at 0, 3 and 12 months
Long term effects of fecal transplantation
time frame: at 12 months
Safety of fecal transplantation in IBS
time frame: during study period (0-12 months)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Recalibrating Intestinal Microflora in IBS by Fecal Transplantation
Principal investigator Rasmus Goll, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.