Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Intestinal microbiota dysbiosis is thought to play an important role in the complex
      pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS
      and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been
      shown to be an effective means of correcting this imbalance in the gut microbiota, especially
      in patients with recurrent Clostridium difficile infections where it has become a preferred
      treatment strategy.

      In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy
      in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal
      bloating was seen three months after transplantation.

      In this study the effects of FMT on patients with IBS without constipation and bloating will
      be investigated in a double blind, placebo controlled RCT.
    

Detailed description: 
      Intestinal microbiota dysbiosis is thought to play an important role in the complex
      pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS
      and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been
      shown to be an effective means of correcting this imbalance in the gut microbiota, especially
      in patients with recurrent Clostridium difficile infections where it has become a preferred
      treatment strategy.

      In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy
      in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal
      bloating was seen three months after transplantation.

      In this study the effects of FMT on patients with IBS without constipation and bloating will
      be investigated in a double blind, placebo controlled RCT. Donors for this study will be
      recruited from a healthy donor pool who will donate stool after clearance of a strict
      inclusion protocol which will assess the presence of any infectious diseases. Stool will be
      frozen following the protocol described in Hamilton et al 2012. Patients will deliver a stool
      portion that will be frozen as well.

      At time of FMT, patients will be randomised in a double blinded fashion to the treatment arm
      (healthy donor stool) or placebo arm (own stool). Transplantation will be preformed by means
      of a colonoscopy with deliverance in the right colon and ileum.

      Following FMT patients will be followed clinically with questionnaires and regular visits to
      the clinic. Stool samples will be collected on a regular basis for microbiome analysis.

      At the end of the study, patients from the placebo-group will be given the opportunity to be
      transplanted with healthy donor stool if necessary. Follow-up will continu for a total
      duration of one year.
    

Intervention name(s): FMT with donor stool; FMT with own stool
Intervention type(s): Procedure; Procedure
Intervention description(s): fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from a healthy pool of donors and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the treatment group; fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from the patients and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the control group
Other intervention name(s): Fecal microbiota transplantation with healthy donor stool; Fecal microbiota transplantation with own stool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: irritable bowel syndrome; fecal microbiota transplantation; bloating