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

NCT04231110 | Completed Phase 4 DMC

• 1 other identifier: 1001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Compliance

  Week 6

• Clinical response

  Week 6

• Endoscopic improvement

  Week 6

• Fecal microbiome

  Week 6

• Mucosal microbiome

  Week 6

Study Arms (1)

FMT and vedolizumab

EXPERIMENTAL

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

Interventions

Fecal microbiota transplantation BIOLOGICAL

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

FMT and vedolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participating in another clinical trial
• Unable to give informed consent
• Severe comorbid medical illness
• 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.
• Pregnant women.
• Clinically significant lactose intolerance
• Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8S4K1, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 18, 2020
• Study Start: May 1, 2021
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)