A randomised controlled trial of faecal microbiota transplantation versus placebo in patients who are non -responders to the low FODMAP diet.
Not Applicable
- Conditions
- Irritable bowel syndromeOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12623000353695
- Lead Sponsor
- Vincent Ho
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1.Aged 18 years old or over
2.Diagnosed with irritable bowel syndrome as per ROME IV criteria
3.An outpatient
4. Lack of symptomatic improvement with the low FODMAP diet
Exclusion Criteria
1. Presence of systemic disease
2. Pregnant, planning pregnancy or lactating.
3. Having undergone any abdominal surgery, with the exception
of appendectomy, cholecystectomy, caesarean section and hysterectomy.
4. Severe psychiatric disorder, or alcohol or drug abuse.
5. Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry
6. Use of IBS medication within the previous 3 months, with the exception of polyethylene glycol and loperamide.
7. Active gastroenteritis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Irritable Bowel Syndrome Symptom Score[1 month post faecal microbiota transplantation]
- Secondary Outcome Measures
Name Time Method IBS-Quality of Life questionnaire<br>[1 - month, 3-month, 6-month and 12-month post transplant];Microbiome dysbiosis index via 16S RNA analysis on stool sample[1 - month, 3-month, 6-month and 12-month post transplant];Cognition function via University of Cambridge, the Cambridge Neuropsychological Test Automated Battery (CANTAB) questionnaire[1 - month, 3-month, 6-month and 12-month post transplant];Microbiome analysis via 16sRNA will be tested on stool sample[1 - month, 3-month, 6-month and 12-month post transplant]