Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial.
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Fecal transplantation; Placebo fecal transplant
Intervention type(s): Biological; Other
Intervention description(s): 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.; Fecal transplantation with own feces
Other intervention name(s): Fecal microbial transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS-D; FMT; metagenomics; gut microbiome