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Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis

NCT01545908 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2015-03-19

No results posted yet for this study

Summary

Ulcerative colitis is a condition that mainly affects young adults where the lining of the bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and treatments remain imperfect with no cure for the disease. Initial success has been shown with a highly novel treatment where patients with active ulcerative colitis receive a fecal enema to try and replace their stool containing bacteria that may be driving their disease with that from a healthy donor. To assess if this works by comparing how well it treats the disease compared to a placebo enema.

Conditions

Interventions

OTHER

Fecal transplant

Participants in this arm undergo 6 retention enemas,using stool specimen prepared from a healthy, screened unrelated donor.

OTHER

Placebo enema

Patients will receive placebo enema, week 1, week 2, week 3, week 4, week 5, week 6

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Christine Lee, MD · St. Joseph's Hamilton Healthcare

  • Paul Moayyedi, MD, FRCP · Hamilton Health Sciences, McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT01545908 on ClinicalTrials.gov