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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
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE April 10, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date January 13, 2017
Study Start Date  ICMJE December 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial.
Official Title  ICMJE Recalibrating Intestinal Microflora in IBS by Fecal Transplantation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • 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
  • Other: Placebo fecal transplant
    Fecal transplantation with own feces
Study Arms  ICMJE
  • Experimental: Fecal transplantation
    Fecal transplantation of freshly prepared feces from healthy donor. Application by colonoscope in proximal half of colon.
    Intervention: Biological: Fecal transplantation
  • Placebo Comparator: Placebo fecal transplantation
    Sham transplant subject's own feces. Application by colonoscope in proximal part of colon.
    Intervention: Other: Placebo fecal transplant
Publications * Johnsen PH, Hilpüsch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2017)
90
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2014)
60
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02154867
Other Study ID Numbers  ICMJE 2013/971/REK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rasmus Goll, PhD University Hospital of North Norway
Study Director: Per C Valle, PhD University Hospital of North Norway
PRS Account University Hospital of North Norway
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP