Irritable Bowel Syndrome
Conditions
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.
Interventions
OTHERFecal Microbiota Transplantation (FMT)
Fecal suspension administered in colonoscopy into the cecum of the patient.
OTHERPlacebo
As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.
Sponsors
Helsinki University Central Hospital
University of Helsinki
Joint Authority for Päijät-Häme Social and Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS symptom relieve | 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.) |
Countries
Finland
Outcome results
None listed