Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · May 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with ulcerative colitis (UC), a condition that causes inflammation of the intestines. The researchers want to see if taking special capsules containing freeze-dried fecal microbiota (which are basically beneficial bacteria from healthy stool) can help prevent UC from coming back and reduce inflammation. The study is currently looking for participants who are at least 18 years old, have had a history of active UC within the last year, and are currently in remission while on stable medication.

Participants in the trial will need to attend regular clinic visits and will be asked to take the capsules daily for a specified period. They will also undergo tests to analyze their gut bacteria and see how it relates to their health during the treatment. It's important to note that some individuals, such as those who are pregnant or have certain medical conditions, may not be eligible to join the study. If you're interested in participating, make sure to discuss it with your doctor to see if it's a good option for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult ≥18 years of age
• • 2. History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria.
• • 3. Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy.
• • 4. Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
• • 5. Female subjects of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
• • 6. Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
• • 7. Subject has an attending physician who will provide the non-FMT care.
• Exclusion Criteria:
• • 1. Unable to take multiple capsules orally.
• • 2. Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
• • 3. Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
• • 4. Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
• • 5. History of recurrent Clostridium difficile infection or FMT in the past 6-months.
• • 6. History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc.
• • 7. Known history of bile acid diarrhea
• • 8. Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent)
• • 9. History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
• • 10. History of use of an investigational drug within 90 days prior to the screening visit.
• • 11. History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
• • 12. Life expectancy of \< 1 year.
• • 13. In the opinion of investigator, subject for any reason, should be excluded from the study.