Fecal Transplantation in Ulcerative Colitis (FMT-CU)
|ClinicalTrials.gov Identifier: NCT03561532|
Recruitment Status : Active, not recruiting
First Posted : June 19, 2018
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: Fecal microbiota transplantation (FMT) Other: Placebo||Not Applicable|
80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).
The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The participant and the treating personnel are blinded of the randomization result.|
|Official Title:||FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS|
|Actual Study Start Date :||October 1, 2016|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Active Comparator: FMT
50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
Other: Fecal microbiota transplantation (FMT)
FMT administered into the cecum of the patient in colonoscopy.
Placebo Comparator: Placebo
50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.
Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.
- Maintenance of remission of ulcerative colitis [ Time Frame: 52 weeks ]Endoscopic remission and Mayo-score < 2
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561532
|Helsinki University Hospital|
|Päijät-Häme Central Hospital|