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

NCT02606032 | Completed Phase 2 DMC

• 1 other identifier: REB# 0163
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis

Keywords

Fecal Microbiota Transplant; Antibiotics

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis

  9 weeks

Study Arms (2)

Metronidazole+doxycylcine+terbinafine

ACTIVE COMPARATOR

Metronidazole 500 mg BID, Doxycycline 100 mg BID, Terbinafine 250 mg once daily all for 14 days

Drug: Metronidazole; Drug: Doxycycline; Drug: Terbinafine

Placebo

PLACEBO COMPARATOR

Placebo Metronidazole, Placebo Doxycycline, and Placebo Terbinafine all BID for 14 days

Drug: Placebo

Interventions

Metronidazole DRUG

active comparator

Also known as: Flagyl

Metronidazole+doxycylcine+terbinafine

Doxycycline DRUG

active comparator

Also known as: Vibramycin

Metronidazole+doxycylcine+terbinafine

Terbinafine DRUG

active comparator

Also known as: Lamisil

Metronidazole+doxycylcine+terbinafine

Placebo DRUG

identical placebos to all antibiotics

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or over
• Active UC defined as a Mayo score \> 3
• A Mayo endoscopic score \> 0

You may not qualify if:

• Participating in another clinical trial
• Unable to give informed consent
• Severe co-morbid medical illness
• Concomitant Clostridium difficile infection
• Severe UC requiring hospitalization.
• 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.
• Antibiotic therapy in the last 30 days.
• Pregnant women.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Hamilton Academic Health Sciences Organization: collaborator

Study Sites (1)

Hamilton Health Sciences / McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Metronidazole; Doxycycline; Terbinafine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Naphthalenes

Study Officials

• Paul Moayyedi, MD

  Hamilton HSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Division of Gastroenterology

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 17, 2015
• Study Start: May 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 27, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)