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New treatment option for Ulcerative Colitis Flare
Official title Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
ClinicalTrials.gov ID: NCT04926103
What this study is testing
- What it's testing
- The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged 18 or over
- Active UC defined as a Mayo score (7) \>3
- A Mayo endoscopic score (7) \>0
- Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the...
You likely can't join if
- Participating in another intervention study for UC
- Unable to give informed consent
- Severe comorbid medical illness
- Severe UC requiring hospitalization.
- Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g...
- Antibiotic therapy in the last 30 days.
See the full eligibility criteria
- Patients aged 18 or over
- Active UC defined as a Mayo score (7) \>3
- A Mayo endoscopic score (7) \>0
- 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
- Participating in another intervention study for UC
- Unable to give informed consent
- Severe comorbid medical illness
- Severe UC requiring hospitalization.
- Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior...
- Antibiotic therapy in the last 30 days.
- Pregnant women.
- Patients with clinically significant hepatic dysfunction at the time of screening: ALT \> 5 times the upper normal range.
- Patients with clinically significant renal dysfunction at the time of screening: serum creatinine \> 300 µmol/L
- Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.