FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- IBS symptom relieve
Study Overview
Brief Summary
52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.
Detailed Description
52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Randomization was done by personnel not treating the patient. The participant or FMT providing personnel did not know the result of randomization. The doctors assessing the outcome have been blinded of the result of randomization.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of IBS based on Rome III criteria
- •Having received traditional treatment for at least 1 month
- •Availability of consecutive fecal samples over one year.
- •Compliance to attend ileocolonoscopy and FMT procedure.
- •18-75 years
Exclusion Criteria
- •Unable to provide informed consent
- •Antibiotic therapy in past 3 months
- •Inflammatory bowel disease (IBD)
Arms & Interventions
FMT
IBS patients randomized to receive FMT from a healthy donor.
Intervention: Fecal Microbiota Transplantation (FMT) (Other)
Placebo
IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
IBS symptom relieve
Time Frame: 52 weeks
Reduction IBS-SSS by 50 points, The irritable bowel severity score system in which the maximum achievable score is 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and \> 300.( Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.)
Secondary Outcomes
No secondary outcomes reported