Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis

NCT01545908 | Completed Phase 2

• 1 other identifier: REB # 11-600
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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

Ulcerative Colitis

Keywords

Fecal transplant; induction of remission; active ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks

  All analyses will be conducted using both intention-to-treat and per-protocol, and the differences in remission rates and relapse rates between the two groups will be statistically analysed. The usual descriptive statistics using Fisher exact test, proportion test, rank test and t-test will be used to compare the two populations making sure that the randomization split the sample into two homogenous sub-samples. Logistic regression and estimating equations will also be used.

  Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.

Secondary Outcomes (1)

• Secondary outcomes include endoscopic and clinical remission defined as a Mayo score = 0 and improvement in symptoms defined as a decrease ≥3 in the Mayo score from baseline at 6 weeks.

  Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.

Study Arms (2)

placebo enema

PLACEBO COMPARATOR

Participants in this arm undergo 6 retention enemas, week 1, week 2, week 3, week 4, week 5, week 6

Other: Placebo enema

Fecal transplant from an unrelated donor

ACTIVE COMPARATOR

Participants in this arm undergo 6 retention enemas,week 1, week 2, week 3, week 4, week 5, week 6,using stool specimen prepared from a healthy, screened donor.

Other: Fecal transplant

Interventions

Fecal transplant OTHER

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

Also known as: Fecal bacteriotherapy, fecal biotherapy.

Fecal transplant from an unrelated donor

Placebo enema OTHER

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

Also known as: saline enema

placebo enema

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 with active UC defined as a Mayo score (13) more than 3 with an endoscopic score more than 0 will be eligible for the study
• Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for more than or equal to 12 weeks prior to randomization.

You may not qualify if:

• Subjects will be excluded if they are participating in another clinical trial, are unable to give informed consent, have severe comorbid medical illness, have concomitant Clostridium difficile infection or have severe UC requiring hospitalization.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (2)

Hamilton Health Sciences / McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Hamilton Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (2)

• Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24.

  PMID: 21871249 RESULT

• Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.

  PMID: 25857665 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Christine Lee, MD

  St. Joseph's Hamilton Healthcare

  PRINCIPAL INVESTIGATOR

• Paul Moayyedi, MD, FRCP

  Hamilton Health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

CA (2)