Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

February 27, 2018

Primary Completion Date

September 25, 2019

Study Completion Date

September 25, 2019

Conditions
PouchitisUlcerative Colitis
Interventions
BIOLOGICAL

Fecal microbiota transplantation

Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.

BIOLOGICAL

Placebo

Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.

Trial Locations (1)

Unknown

Helsinki University Central Hospital, Helsinki

All Listed Sponsors
lead

Helsinki University Central Hospital

OTHER

NCT03378921 - Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis | Biotech Hunter | Biotech Hunter