NCT04231110CompletedPhase 4
Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 2 Jan 2020
- Start date
- 1 May 2021
- Primary completion date
- 18 Nov 2024
- Lead sponsor
- McMaster University
- Diseases
- Ulcerative colitis
- NCT number
- NCT04231110
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 6
- From 1 May 2021 to the primary completion date, 18 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Severe comorbid medical illness
- Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results
Other
- Participating in another clinical trial
- Unable to give informed consent
- Pregnant women.
- Clinically significant lactose intolerance
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hamilton Health Sciences Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.