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

Last updated: February 5, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

2

Condition

Inflammation

Inflammatory Bowel Disease

Crohn's Disease

Treatment

PRIM-DJ2727

Placebos

Clinical Study ID

NCT04373473
HSC-MS-20-0316
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult ≥18 years of age
  2. History of active UC in the past 12 months based on standard clinical, endoscopic, orhistologic 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 usean effective method of birth control during the study.
  5. Female subjects of childbearing potential must have a negative urine Qualitative HCGpregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior toadministration of study drug.
  6. Willing and able to sign an informed consent form and attend all study-related clinicvisits, assessments, and follow-up phone calls.
  7. Subject has an attending physician who will provide the non-FMT care.

Exclusion

Exclusion Criteria:

  1. Unable to take multiple capsules orally.
  2. Females who are pregnant, breastfeeding, or planning to become pregnant during thestudy.
  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, diverticulitisetc.
  7. Known history of bile acid diarrhea
  8. Compromised immune system (e.g. primary immune disorders or clinical immunosuppressiondue to a medical condition or medication e.g. taking oral prednisone >20 mg a day orprednisone-equivalent)
  9. History of active cancer and/or ongoing chemotherapy (superficial non-metastaticcancers 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 studyinvestigator 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 thestudy.

Study Design

Total Participants: 58
Treatment Group(s): 2
Primary Treatment: PRIM-DJ2727
Phase: 2
Study Start date:
September 14, 2020
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

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