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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Biological: Fecal transplantation; Other: Placebo fecal transplant

• Registration Number: NCT02154867
• Lead Sponsor: University Hospital of North Norway

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Study Start: 2014-12
• Status Verified: 2015-01
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal transplantation	Fecal transplantation	Fecal transplantation of freshly prepared feces from healthy donor. Application by colonoscope in proximal half of colon.
Placebo fecal transplantation	Placebo fecal transplant	Sham transplant subject's own feces. Application by colonoscope in proximal part of colon.

Primary Outcome Measures

Name	Time	Method
Change in subjective symptom score	at 0 and 3 months	Comparison of Irritable bowel syndrome severity scoring system (IBS-SSS) grade assessment before and after fecal transplantation

Secondary Outcome Measures

Name	Time	Method
Long term effects of fecal transplantation	at 12 months	Assessment of symptom burden by IBS-SSS
Safety of fecal transplantation in IBS	during study period (0-12 months)	Registration of any adverse events. If any serious adverse events are encountered, the study group and local ethics committee will evaluate if study should be terminated.
Microbiome profile change	at 0, 3 and 12 months	Characterization of fecal microbiome by metagenomic analysis before and after intervention

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Harstad, Norway