Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial. (REFIT)
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|ClinicalTrials.gov Identifier: NCT02154867|
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : January 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Biological: Fecal transplantation Other: Placebo fecal transplant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Recalibrating Intestinal Microflora in IBS by Fecal Transplantation|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Fecal transplantation
Fecal transplantation of freshly prepared feces from healthy donor. Application by colonoscope in proximal half of colon.
Biological: Fecal 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.
Other Name: Fecal microbial transplantation
Placebo Comparator: Placebo fecal transplantation
Sham transplant subject's own feces. Application by colonoscope in proximal part of colon.
Other: Placebo fecal transplant
Fecal transplantation with own feces
- Change in subjective symptom score [ Time Frame: at 0 and 3 months ]Comparison of Irritable bowel syndrome severity scoring system (IBS-SSS) grade assessment before and after fecal transplantation
- Microbiome profile change [ Time Frame: at 0, 3 and 12 months ]Characterization of fecal microbiome by metagenomic analysis before and after intervention
- Long term effects of fecal transplantation [ Time Frame: at 12 months ]Assessment of symptom burden by IBS-SSS
- Safety of fecal transplantation in IBS [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154867
|University Hospital of North Norway|
|Harstad, Norway, 9406|
|Principal Investigator:||Rasmus Goll, PhD||University Hospital of North Norway|
|Study Director:||Per C Valle, PhD||University Hospital of North Norway|