Oral fecal microbiota transplant for preventing ulcerative colitis relapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of lyophilized PRIM-DJ2727 capsules administered orally to adults with ulcerative colitis who are in remission. Participants will receive either the active treatment or a placebo, and their gut microbiota will be analyzed over time to identify any associations with clinical outcomes. The study aims to provide insights into the potential benefits of fecal microbiota transplantation in maintaining remission and preventing inflammation in ulcerative colitis patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Herbert DuPont, md
• Email: herbert.l.dupont@uth.tmc.edu
• Phone: 713 500 6687

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.