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

Irritable Bowel Syndrome Clinical Trial

— REFIT  

Official title:

Recalibrating Intestinal Microflora in IBS by Fecal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154867
• Other study ID #: 2013/971/REK
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2014
• Last updated: January 12, 2017
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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:
• Placebo fecal transplant
Fecal transplantation with own feces

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Harstad

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subjective symptom score	Comparison of Irritable bowel syndrome severity scoring system (IBS-SSS) grade assessment before and after fecal transplantation	at 0 and 3 months
Secondary	Microbiome profile change	Characterization of fecal microbiome by metagenomic analysis before and after intervention	at 0, 3 and 12 months
Secondary	Long term effects of fecal transplantation	Assessment of symptom burden by IBS-SSS	at 12 months
Secondary	Safety of fecal transplantation in IBS	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.	during study period (0-12 months)