Trial Details

Not Recruiting
Basic Information
Clinical ID c2241
Identifier ACTRN12622001434785
Trial Title Maintaining Remission of Ulcerative Colitis with __Faecal Microbiota Transplantation: the MR-UC-FMT Trial
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Ulcerative Colitis;Inflammatory Bowel Disease; Ulcerative Colitis Inflammatory Bowel Disease;Oral and Gastrointestinal - Inflammatory bowel disease;Inflammatory and Immune System - Autoimmune diseases
Interventions All patients will receive Prednisolone 50mg oral tablet daily for Week 1, Prednisolone 37.5mg oral tablet daily for Week 2, Prednisolone 25mg oral tablet daily for Week 3 and 4, Prednisolone 20mg oral tablet daily for week 5, Prednisolone 15mg oral tablet daily for Week 6, Prednisolone 10mg oral tablet daily for Week 7 and Prednisolone 5mg daily oral tablet for Week 8 then cease. Faecal Microbial Transplantation (FMT) is anaerobically prepared blended donor stool with 65% normal saline and 10% glycerol. FMT administered 200mL into the caecum via colonoscopy (duration of procedure of 20 minutes, patient to remain on right side for a further 60 minutes in recovery to help retain FMT) by accredited gastroenterologist after 4 weeks of Prednisolone therapy once on Day 1 of Week 5. Administered FMT 60mL into rectum via enema administered by gastroenterologist or gastroenterology registrar by syringe on two non-consecutive days (eg Day 4+6 or Day 5+7) following the colonoscopic FMT during week 5. Days given depend on patient and proceduralist availability. Patient to remain prone for at least 30 minutes post insertion of FMT enema, and encouraged to defer opening bowels as long as comfortable. If in remission (defined as Mayo score less than or equal to 2 with no individual subscore greater than 1) or had an adequate clinical response (reduction in Total Mayo score of greater than or equal to 30% and 3points or more, as well as a reduction in the rectal bleeding score of greater than or equal to 1 or a rectal bleeding score of 0 or 1) at week 12, patients enter Phase 2 which begins at week 13. They will be openly randomised. There is no placebo group. Intervention group receives 60mL FMT enema 4 weekly for 9 months. Patients who are not deemed to be in rem
Participant Information
Sponsor Central Adelaide Local Health Network
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date 2022-11-08
Completion Date 2021-02-04