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Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Recruiting

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Fecal microbiota transplantation

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged 18 or over
Active UC defined as total Mayo score of 6 or more points, with endoscopic subscore at > 2
Clinician initiating vedolizumab for patients as per standard of care for UC
Patient previously has been exposed to one or more biologic or advanced therapies (anti-TNF, JAK inhibitor, anti-interleukin) and never previously exposed to vedolizumab or other anti-integrin therapy.
Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Exclusion Criteria:

Participating in another clinical trial
Unable to give informed consent
Severe comorbid medical illness
Concomitant Clostridium difficile infection
Increase in medical therapy for UC in the last 4 weeks. Continued treatment with 5-ASA, azathioprine, or 6-mercaptopurine will be permitted if taken at stable dose for ≥4 weeks prior to study entry. 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.
New antibiotic therapy in the last 28 days.
Dose of infliximab or golimumab in prior four weeks, adalimumab in prior two weeks, or tofacitinib in prior one week.
Pregnant women.
Clinically significant lactose intolerance
Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results

Sites / Locations

Hamilton Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT and vedolizumab

Arm Description

People who are initiating vedolizumab per standard of care for ulcerative colitis will also be offered FMT weekly for 6 weeks.

Outcomes

Primary Outcome Measures

Clinical remission

The primary outcome of this pilot trial is rate of remission of UC, defined as a total Mayo score of 2 or less, with no subscore greater than 1, and endoscopic healing with a endoscopic subscore of 0 or 1.

Secondary Outcome Measures

Compliance

Evaluate the number of patients who complete all their FMT and vedolizumab induction visits

Clinical response

Evaluation of fecal microbiota transplant and vedolizumab for rate of clinical response (defined as reduction of Mayo score of 2 or more points) at the end of the trial.

Endoscopic improvement

Evaluation of fecal microbiota transplant and vedolizumab at rate of endoscopic improvement (defined as reduction of endoscopic Mayo score of 1 or more) at the end of the trial.

Fecal microbiome

Compare the fecal microbiome in UC patients in remission versus still active at the end of the trial.

Mucosal microbiome

Compare the mucosal microbiome in UC patients in remission versus still active at the end of the trial.

Adverse events

Qualitative evaluation of adverse events in patients receiving fecal microbiota transplant and vedolizumab

Full Information

NCT ID

NCT04231110

First Posted

January 2, 2020

Last Updated

October 18, 2023

Sponsor

McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT04231110

Brief Title

Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

Official Title

Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a pilot study of combination therapy using FMT and vedolizumab for induction of UC. The investigators hypothesize that a combination therapy approach which addresses immune trafficking and microbial manipulation simultaneously will lead to superior outcomes than those seen with single agent therapy.

Detailed Description

This is a prospective pilot trial involving a single centre (McMaster University Medical Centre) recruiting patients from Hamilton, Ontario Canada and the surrounding regions, to evaluate efficacy and safety outcomes when using fecal microbiota transplantation once weekly for six weeks in UC patients who are initiated on vedolizumab. A lead in study will be conducted with the first five patients to ensure engraftment of FMT within the colon. Interim analysis will be conducted after these five patients to ensure engraftment within the colon. Data Safety and Monitoring Board will also be informed of the results after the first five patients, including any adverse events. Decision will be made based on these results whether to proceed with the prospective study using FMT weekly for six weeks, or whether to modify the dose/frequency of FMT treatment. As patients with previous biologic failure tend to have sub-optimal response to vedolizumab monotherapy, this pilot study will focus on recruitment of previous biologic failure patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FMT and vedolizumab

Arm Type

Experimental

Arm Description

People who are initiating vedolizumab per standard of care for ulcerative colitis will also be offered FMT weekly for 6 weeks.

Intervention Type

Biological

Intervention Name(s)

Fecal microbiota transplantation

Intervention Description

Use of fecal microbiota transplantation enemas once weekly in patients who are initiating vedolizumab treatment

Primary Outcome Measure Information:

Title

Clinical remission

Description

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Compliance

Description

Evaluate the number of patients who complete all their FMT and vedolizumab induction visits

Time Frame

Week 6

Title

Clinical response

Description

Evaluation of fecal microbiota transplant and vedolizumab for rate of clinical response (defined as reduction of Mayo score of 2 or more points) at the end of the trial.

Time Frame

Week 6

Title

Endoscopic improvement

Description

Evaluation of fecal microbiota transplant and vedolizumab at rate of endoscopic improvement (defined as reduction of endoscopic Mayo score of 1 or more) at the end of the trial.

Time Frame

Week 6

Title

Fecal microbiome

Description

Compare the fecal microbiome in UC patients in remission versus still active at the end of the trial.

Time Frame

Week 6

Title

Mucosal microbiome

Description

Compare the mucosal microbiome in UC patients in remission versus still active at the end of the trial.

Time Frame

Week 6

Title

Adverse events

Description

Qualitative evaluation of adverse events in patients receiving fecal microbiota transplant and vedolizumab

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18 or over Active UC defined as total Mayo score of 6 or more points, with endoscopic subscore at > 2 Clinician initiating vedolizumab for patients as per standard of care for UC Patient previously has been exposed to one or more biologic or advanced therapies (anti-TNF, JAK inhibitor, anti-interleukin) and never previously exposed to vedolizumab or other anti-integrin therapy. Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance Exclusion Criteria: Participating in another clinical trial Unable to give informed consent Severe comorbid medical illness Concomitant Clostridium difficile infection Increase in medical therapy for UC in the last 4 weeks. Continued treatment with 5-ASA, azathioprine, or 6-mercaptopurine will be permitted if taken at stable dose for ≥4 weeks prior to study entry. 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. New antibiotic therapy in the last 28 days. Dose of infliximab or golimumab in prior four weeks, adalimumab in prior two weeks, or tofacitinib in prior one week. Pregnant women. Clinically significant lactose intolerance Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Habashi, RN

Phone

905-521-2100

Ext

73884

habashp@hhsc.ca

Facility Information:

Facility Name

Hamilton Health Sciences

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S4K1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carla Rayan

rayanc@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

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