Oral fecal microbiota transplant for preventing ulcerative colitis relapse

A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

This study is testing whether taking special capsules made from gut bacteria can help adults with ulcerative colitis stay in remission and avoid flare-ups.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT04373473 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of active ulcerative colitis in the past year who are currently in remission.

Not a fit: Patients who are unable to take multiple capsules orally or who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help prevent relapse and manage intestinal inflammation in patients with ulcerative colitis.

How similar studies have performed: Other studies have shown promise with fecal microbiota transplantation, but this specific oral approach is relatively novel.

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.

Where this trial is running

Houston, Texas

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

Study contacts

• Study coordinator: Herbert DuPont, md

Conditions Adults With Ulcerative Colitis