Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis

March 17, 2015 updated by: Paul Moayyedi, Hamilton Health Sciences Corporation

A Randomized Controlled Trial of Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypothesis Fecal biotherapy will be more effective than placebo at inducing remission in patients with active UC.

Approach and work plan 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. 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. 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 or equal to 12 weeks prior to randomization. Eligible patients will be randomized to receive fecal biotherapy or placebo. Fecal biotherapy will be provided by an unrelated donor who is able to give informed consent, travel to the treatment centre at St Joseph's Hospital, Hamilton and able to collect fecal sample as needed for the fecal transplantation protocol. Fecal microbiome profiling will be carried out using both Roche 454 pyrosequencing and Illumina sequencing.

One hundred and thirty active UC patients will be randomized 1:1 according to a computer generated randomization list. Randomization will be administered centrally at the GI Clinical Trials Unit to ensure concealment of allocation. Eligible patients will be randomized to receive a weekly fecal biotherapy enema or a placebo enema for six weeks. In order to mitigate a placebo effect, both the patient and study staff will be blinded to the allocation of the treatment. An unblinded, independent laboratory technologist will prepare the retention enema according to the treatment arm to which the patient is assigned. The enema containers will be fully colour-tinted from the tip to the bottom of the container. The container will be placed inside a paper bag, which contains baking soda to absorb the odor. Both the patient and the study nurse will be required to wear a tightly fitted mask at all times during the infusion and retention of the enema.

Subjects will have a sigmoidoscopy (or colonoscopy if clinically indicated), physician assessment and complete a Mayo score (13) and IBDQ questionnaire (15) at baseline. The physician assessment, IBDQ and partial Mayo score (Mayo score without the sigmoidoscopy) will be repeated at 3 weeks. A repeat sigmoidoscopy, physician assessment IBDQ and Mayo score will be completed at 6 weeks, at exit from the study. No new medical therapies (e.g. corticosteroids, antibiotics, probiotics) will be permitted during the six-week study period. At the end of the treatment component of the study, fecal biotherapy will be offered to the participants in the placebo arm with clinical and sigmoidoscopic evidence of active UC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences / McMaster University
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Hamilton Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo enema
Participants in this arm undergo 6 retention enemas, week 1, week 2, week 3, week 4, week 5, week 6
Other: Placebo enema
Patients will receive placebo enema, week 1, week 2, week 3, week 4, week 5, week 6
Other Names:
  • saline enema
Active Comparator: Fecal transplant from an unrelated donor
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
Participants in this arm undergo 6 retention enemas,using stool specimen prepared from a healthy, screened unrelated donor.
Other Names:
  • Fecal bacteriotherapy, fecal biotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamilton Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Lee, MD, St. Joseph's Hamilton Healthcare
  • Principal Investigator: Paul Moayyedi, MD, FRCP, Hamilton Health Sciences, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB # 11-600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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