Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
Status:
Completed
Trial end date:
2021-01-27
Target enrollment:
Participant gender:
Summary
The investigators will test the hypothesis that giving antibiotics prior to fecal transplant
therapy for active UC increases the proportion of patients in remission at the end of
treatment. The investigators will randomize patients aged 18 or over with active UC to
antibiotics (metronidazole 500mg, doxycycline 100mg, Terbinafine 250 mg, all twice daily for
two weeks); or identical placebo. At the end of two weeks the investigators will give all
patients fecal transplant therapy twice per week for eight weeks from an anonymous donor
stool.). Patients will complete a validated UC questionnaire, have a flexible sigmoidoscopy
to assess the degree of inflammation in the colon and complete general and disease specific
quality of life questionnaire as well as a questionnaire on anxiety and depression. Patients
will complete the same questionnaires again at the end of treatment at week 9 when they will
also have a repeat flexible sigmoidoscopy. The main outcome that will be assessed is the
proportion of patients in remission from their UC at the end of treatment.