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

Sponsor
McMaster University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04231110
Collaborator
(none)
10
1
1
26
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Fecal microbiota transplantation
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: FMT and vedolizumab

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

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

Outcome Measures

Primary Outcome Measures

  1. Clinical remission [Week 6]

    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

  1. Compliance [Week 6]

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

  2. Clinical response [Week 6]

    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.

  3. Endoscopic improvement [Week 6]

    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.

  4. Fecal microbiome [Week 6]

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

  5. Mucosal microbiome [Week 6]

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

  6. Adverse events [Week 6]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients aged 18 or over

  2. Active UC defined as total Mayo score of 6 or more points, with endoscopic subscore at

2

  1. Clinician initiating vedolizumab for patients as per standard of care for UC

  2. 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.

  3. 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:
  1. Participating in another clinical trial

  2. Unable to give informed consent

  3. Severe comorbid medical illness

  4. Concomitant Clostridium difficile infection

  5. 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.

  6. New antibiotic therapy in the last 28 days.

  7. Dose of infliximab or golimumab in prior four weeks, adalimumab in prior two weeks, or tofacitinib in prior one week.

  8. Pregnant women.

  9. Clinically significant lactose intolerance

  10. Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hamilton Health Sciences Hamilton Ontario Canada L8S4K1

Sponsors and Collaborators

  • McMaster University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
McMaster University
ClinicalTrials.gov Identifier:
NCT04231110
Other Study ID Numbers:
  • 1001
First Posted:
Jan 18, 2020
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022