Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| University of Helsinki | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT | Active Comparator | IBS patients randomized to receive FMT from a healthy donor. |
|
| Placebo | Placebo Comparator | IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Other | Fecal suspension administered in colonoscopy into the cecum of the patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 52 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Perttu Arkkila, Adj. Prof. | +358 9 4711 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32343000 | Derived | Lahtinen P, Jalanka J, Hartikainen A, Mattila E, Hillila M, Punkkinen J, Koskenpato J, Anttila VJ, Tillonen J, Satokari R, Arkkila P. Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome. Aliment Pharmacol Ther. 2020 Jun;51(12):1321-1331. doi: 10.1111/apt.15740. Epub 2020 Apr 28. |
Not provided
Not provided
Individual participant data will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
Not provided
Not provided
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.
| Placebo | Other | As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy. |
|
| D004066 | Digestive System Diseases |