Ulcerative Colitis Clinical Trial
Official title:
Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis
NCT number | NCT04231110 |
Other study ID # | 1001 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | December 30, 2024 |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 3. Clinician initiating vedolizumab for patients as per standard of care for UC 4. 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. 5. 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Week 6 | |
Secondary | Compliance | Evaluate the number of patients who complete all their FMT and vedolizumab induction visits | Week 6 | |
Secondary | 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. | Week 6 | |
Secondary | 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. | Week 6 | |
Secondary | Fecal microbiome | Compare the fecal microbiome in UC patients in remission versus still active at the end of the trial. | Week 6 | |
Secondary | Mucosal microbiome | Compare the mucosal microbiome in UC patients in remission versus still active at the end of the trial. | Week 6 | |
Secondary | Adverse events | Qualitative evaluation of adverse events in patients receiving fecal microbiota transplant and vedolizumab | Week 6 |
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