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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

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Biological: Fecal transplantation Other: Placebo fecal transplant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Microbiome profile change [ Time Frame: at 0, 3 and 12 months ]
    Characterization of fecal microbiome by metagenomic analysis before and after intervention

  2. Long term effects of fecal transplantation [ Time Frame: at 12 months ]
    Assessment of symptom burden by IBS-SSS

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Norway
University Hospital of North Norway
Harstad, Norway, 9406
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Principal Investigator: Rasmus Goll, PhD University Hospital of North Norway
Study Director: Per C Valle, PhD University Hospital of North Norway

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02154867     History of Changes
Other Study ID Numbers: 2013/971/REK
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2015
Keywords provided by University Hospital of North Norway:
IBS-D
FMT
metagenomics
gut microbiome
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases