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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04373473
Other study ID # HSC-MS-20-0316
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 14, 2020
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source The University of Texas Health Science Center, Houston
Contact Herbert DuPont, md
Phone 713 500 6687
Email herbert.l.dupont@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 58
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
PRIM-DJ2727
Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product.
Placebos
Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score = 3 9 months
Secondary Quality of life will be characterized by health-related quality of life score. 9 months
Secondary Subject-reported score in Hospital Anxiety and Depression Scale After administering 12 weeks of PRIM-DJ2727 9 months