Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Jun 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of fecal microbiota transplant (FMT) on patients with active ulcerative colitis (UC), a condition that causes inflammation in the lining of the intestines. Researchers believe that the stool from certain donors may work better than others in helping patients go into remission, which means reducing or eliminating their symptoms. The goal of this study is to find new effective donors and to follow how well the FMT works for patients over time.

To be eligible for this trial, participants must be 18 years or older and have active UC, which is measured by specific scores indicating their symptoms and inflammation levels. Patients who are currently involved in other studies or have certain severe health conditions may not qualify. Those who join can expect to receive FMT and will be monitored long-term to see how their condition improves. This study aims to help researchers understand if ongoing FMT can lead to lasting improvements in UC symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 18 or over
• • 2. Active UC defined as a Mayo score (7) \>3
• • 3. A Mayo endoscopic score (7) \>0
• • 4. 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
• Exclusion Criteria:
• • 1. Participating in another intervention study for UC
• • 2. Unable to give informed consent
• • 3. Severe comorbid medical illness
• • 4. Severe UC requiring hospitalization.
• • 5. 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 to randomization. Relapse on a 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.
• • 6. Antibiotic therapy in the last 30 days.
• • 7. Pregnant women.
• • 8. Patients with clinically significant hepatic dysfunction at the time of screening: ALT \> 5 times the upper normal range.
• • 9. Patients with clinically significant renal dysfunction at the time of screening: serum creatinine \> 300 µmol/L
• • 10. Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.