Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis

• Status: Completed
• Trial end date: 2021-01-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: Hamilton Academic Health Sciences Organization
• Treatments: Anti-Infective Agents; Doxycycline; Metronidazole; Terbinafine

Criteria

Inclusion Criteria:

1. Patients aged 18 or over

2. Active UC defined as a Mayo score > 3

3. A Mayo endoscopic score > 0

Exclusion Criteria:

1. Participating in another clinical trial

2. Unable to give informed consent

3. Severe co-morbid medical illness

4. Concomitant Clostridium difficile infection

5. Severe UC requiring hospitalization.

6. Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF alpha therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.

7. Antibiotic therapy in the last 30 days.

8. Pregnant women.