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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hamilton Health Sciences
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.