NCT03561532

Fecal Transplantation in Ulcerative Colitis

FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Joint Authority for Päijät-Häme Social and Health Care · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.

Detailed description

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Fecal microbiota transplantation (FMT)	FMT administered into the cecum of the patient in colonoscopy.
OTHER	Placebo	Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2018-06-19
• Last updated: 2019-08-15

Locations

2 sites across 1 country: Finland