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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult ≥18 years of age
- History of active UC in the past 12 months based on standard clinical, endoscopic, orhistologic criteria.
- Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy.
- Sexually active male and female subjects of childbearing potential must agree to usean effective method of birth control during the study.
- 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.
- Willing and able to sign an informed consent form and attend all study-related clinicvisits, assessments, and follow-up phone calls.
- Subject has an attending physician who will provide the non-FMT care.
Exclusion
Exclusion Criteria:
- Unable to take multiple capsules orally.
- Females who are pregnant, breastfeeding, or planning to become pregnant during thestudy.
- Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
- Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
- History of recurrent Clostridium difficile infection or FMT in the past 6-months.
- 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.
- Known history of bile acid diarrhea
- 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)
- History of active cancer and/or ongoing chemotherapy (superficial non-metastaticcancers and maintenance chemotherapy are permitted).
- History of use of an investigational drug within 90 days prior to the screening visit.
- History of significant uncontrolled systemic disease that in the opinion of the studyinvestigator could interfere with study participation and/or objectives.
- Life expectancy of < 1 year.
- 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 StatesActive - Recruiting
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