An interventional study of Fecal Microbiota Transplantation (FMT) and Placebo in Irritable Bowel Syndrome, sponsored by Joint Authority for Päijät-Häme Social and Health Care. Completed at 1 site in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by Joint Authority for Päijät-Häme Social and Health Care · Not applicable, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 52 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Joint Authority for Päijät-Häme Social and Health Care is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IBS patients randomized to receive FMT from a healthy donor.
Other: Fecal Microbiota Transplantation (FMT)
IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo.
Other: Placebo
Fecal suspension administered in colonoscopy into the cecum of the patient.
As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.
IBS symptom relieve
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.)
Time frame: 52 weeks
Plan to share: No — Individual participant data will not be shared.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Joint Authority for Päijät-Häme Social and Health Care