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

NCT02606032 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metronidazole

active comparator

DRUG

Doxycycline

active comparator

DRUG

Terbinafine

active comparator

DRUG

Placebo

identical placebos to all antibiotics

Sponsors & Collaborators

  • Hamilton Academic Health Sciences Organization

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Paul Moayyedi, MD · Hamilton HSC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-01-31
Completion
2021-01-27

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02606032 on ClinicalTrials.gov