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Microbial Manipulation

Combination Therapy for Ulcerative Colitis

Phase 4
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 18 or over
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.
Must not have
New antibiotic therapy in the last 28 days.
Clinically significant lactose intolerance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new combination therapy for UC that may be more effective than existing treatments.

Who is the study for?
Adults with active Ulcerative Colitis (UC) who have tried other biologic therapies but not vedolizumab or anti-integrin therapy. They must be starting vedolizumab as standard care, have a Mayo score of 6+ with an endoscopic subscore over 2, and women must use approved contraception. Excluded are those in another trial, unable to consent, severe illness, recent antibiotics or changes in UC meds.
What is being tested?
The study tests combining Fecal Microbiota Transplantation (FMT) with the drug Vedolizumab for treating UC. The hypothesis is that tackling both immune trafficking and gut microbes together might work better than either approach alone.
What are the potential side effects?
Potential side effects may include typical reactions to fecal transplants like bloating and diarrhea, plus Vedolizumab-related risks such as headache, joint pain, nausea or infections due to immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have tried some advanced therapies but not vedolizumab or anti-integrin treatments.
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My ulcerative colitis is active with a Mayo score of 6 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not started any new antibiotics in the last 28 days.
Select...
I have a severe reaction to lactose.
Select...
I currently have a Clostridium difficile infection.
Select...
I am unable to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical remission
Secondary study objectives
Adverse events
Clinical response
Compliance
+3 more

Side effects data

From 2019 Phase 2 trial • 26 Patients • NCT03378921
8%
fever
8%
fecal urgency
8%
abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donors Feces
Patients Own Feces

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FMT and vedolizumabExperimental Treatment1 Intervention
People who are initiating vedolizumab per standard of care for ulcerative colitis will also be offered FMT weekly for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vedolizumab
FDA approved

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,218 Total Patients Enrolled
3 Trials studying Colitis
173 Patients Enrolled for Colitis
~0 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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