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

Korábbi kezelés

• 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.

Más betegség

• 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

Egyéb

• Participating in another clinical trial
• Unable to give informed consent
• Pregnant women.
• Clinically significant lactose intolerance

• 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