Examining the role of FMT in inducing clinical remission in Ulcerative Proctitis
Examining the role of Faecal Microbiota Transplantation (FMT) in inducing clinical remission in Ulcerative Proctitis (UP-FMT Trial)
The Queen Elizabeth Hospital Inflammatory Bowel Disease (IBD) service is currently running a trial to study the role of FMT in inducing clinical remission in Ulcerative Proctitis. The aim is to recruit 25 patients across South Australia. The trial is being run by Dr Sibhi Raja who is conducting this trial as part of his master’s degree with the University of Adelaide.
It is a single centre, prospective open label intervention study. This means all patients will receive the same FMT treatment.
Who can participate?
The trial is open to patients aged 18-80 who have Ulcerative Proctitis less than 30cm from the anal verge (which will be confirmed with a baseline flexible sigmoidoscopy).
They must have a Clinical Mayo score of 3-10, with an endoscopic sub-score greater than 0.
Patients must also have current or prior use of oral or topical 5-ASA therapy.
Therapy must be stable, and meet the following requirements:
- No therapy for 4 weeks.
- Stable dose of oral and/or topical 5-aminosalicylic acid therapy for 4 weeks.
- Stable dose of immunomodulator therapy (azathioprine, mercaptopurine, or methotrexate) for 6 weeks.
- Stable dose of biologic therapy (infliximab, adalimumab, vedolizumab) for 8 weeks.
What can participants expect?
Participants will be given an 8 week course of vancomycin and general dietary advice. 6 FMT enemas administered at weeks 0, 1, 2, 3, 5 and 7 at the Queen Elizabeth Hospital gastroenterology department.
Find out more
To find out more email firstname.lastname@example.org
Contributed by Dr Sihbi Sreecanth Raja, The Queen Elizabeth Hospital