None listed
Conditions
Brief summary
Maintenance of Remission for Ulcerative Colitis with Faecal Microbiota Transplantation; the MR-UC-FMT trial is prospective clinical trial designed to determine the dosing interval of Faecal Microbiota Transplantation administered by enema with a view to maintain remission following induction with FMT and prednisolone. The study recruits patients with mild to moderate Ulcerative Colitis and enrols them into two phases of the trial. The first phase involves an 8 week course of prednisolone with a Faecal Microbiota Transplantation given via colonosopy at week 5 with a view to induce remission or adequate clinical response. Those patients who respond to treatment will be openly randomised to receive FMT via clinician administered enema every 4 or 8 weeks for a further 40 weeks (total 52 weeks). The study aims to test the hypothesis that: -FMT given more frequently via enema is more likely to result in the patient's microbiome becoming more similar to the FMT than the patient's baseline microbiome. -The therapeutic effect of FMT is that the bacteria in the patient's colon become the same as those in the transplant material. -The therapeutic effect of FMT is to improve the diversity of bacteria in the patient's colon -FMT is more effective if given with prednisolone for induction of remission. -FMT given more frequently improves outcomes including time to flare, weeks in flare and clinical or endoscopic remission at 28 and 52 weeks.
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% g
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 remission at week 12 will be discharged from the study back to their referring Gastroenterologist for treatment outside the scope of the trial. Enemas are administered by proceduralist to ensure adherence. Adherence to Prednisolone is assessed with verbal checks with patient prior to commencing, and at 4 and 8 week interviews. During phase 2, if flare occurs patient to be referred to Gastroenterologist to discussion around escalation of treatment, however no further prednisolone is prescribed as a routine part of phase 2.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 18 - 75 years Formal diagnosis of UC for greater than or equal to 1 month Currently under the care of a gastroenterologist Mild to Moderately Active UC with Total Mayo score 3 to 10 inclusive. Mayo Endoscopic Sub Score greater than or equal to 2 (to ensure symptoms are due to UC and not due to a concurrent functional bowel disorder)
Exclusion criteria
Severe UC with Total Mayo score of greater than or equal to 11 or by Truelove Witts Criteria Diminished mental capacity preventing consent Pregnancy Surgical resection of any part of the intestine Anticoagulation or dual antiplatelet use Antibiotic use at time of enrolment Contraindications to the use of prednisolone (e.g. poorly controlled Diabetes Mellitus, history of steroid-induced mental health complications such as depression, mania or psychosis) Plans for travel from South Australia for >4 weeks during the 12 months study period
Outcome results
None listed