Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Procedure: FMT with donor stoolProcedure: FMT with own stool
- Registration Number
- NCT02299973
- Lead Sponsor
- University Hospital, Ghent
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group (FMT with donor stool) FMT with donor stool Fecal microbiota transplantation with healthy donor stool Placebo group (FMT with own stool) FMT with own stool Fecal microbiota transplantation with patient's own stool
- Primary Outcome Measures
Name Time Method Reduction of overall IBS symptoms (Key question 1) 3 months after FMT On a weekly basis patients will assess their overall IBS symptoms by answering a key question (Are your overall symptoms improved as compared to before the treatment?)
Reduction of abdominal bloating (Key question 2) 3 months after FMT On a weekly basis patients will assess their sensation of abdominal bloating by answering a key question (Is your overall sensation of bloating improved by FMT as compared to before treatment?)
- Secondary Outcome Measures
Name Time Method Changes in IBS symptom scores at three months after FMT 3 months after FMT IBS symptoms will be assessed by use of a daily symptom diary which will measure abdominal discomfort, pain, bloating, flatulence, stool frequency, stool consistency and urgency
Changes in IBS symptom scores at six months post FMT 6 months Key questions and symptom diary scores will be repeated 6 months after FMT to assess the duration of effects
Composition of mucosal-adherent microbiota (Illumina sequencing) 3 months Composition of mucosal-adherent microbiota will be assessed by Illumina sequencing. Biopsies will be taken at time of FMT and snap frozen for further analysis.
Changes in IBS symtom scores at 9 months post FMT 9 months Key questions and symptom diary scores will be repeated 9 months after FMT to assess the duration of effects
Changes of IBS symptom scores in patients who undergo an off-trial FMT 3 months After unblinding patients who were included in the placebo group, will be offered the possibility of FMT. Effects in these patients will be followed by IBS symptoms scores and answers to key questions at 3 months post FMT
Changes in fecal microbiome composition (Illumina sequencing) 3 months after FMT Before and after FMT stool samples will be collected on a regular basis to assess the changes in microbiome changes (Illumina sequencing).
Changes in IBS symptom scores at 1 year post FMT 1 year Key questions and symptom diary scores will be repeated 1 year after FMT to assess the duration of effects
Trial Locations
- Locations (1)
Ghent University Hospital
🇧🇪Ghent, Belgium