Recruiting
Phase 1

FMT

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05786404

Conditions

Active Ulcerative Colitis (UC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRIM-DJ2727 - FROZEN

PRIM-DJ2727 - CAPSULES

Study Details

Brief summary:

The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.

Conditions

Active Ulcerative Colitis (UC)

Study ID

NCT05786404

Start date

Dec 15, 2023

Status verified date

May, 2024

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore >1)
  • Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
  • Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
  • Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
  • Subject has an attending physician who will provide the non-FMT care.

Exclusion Criteria:

  • Subjects with sever UC (Mayo score of >7)
  • Unable to take retention enema or multiple capsules orally.
  • Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • 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, diverticulitis etc.
  • Known history of bile acid diarrhea
  • 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)
  • History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers 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 study investigator 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 the study.
  • Absolute neutrophil count (ANC) < 500IU/mL

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: PRIM-DJ2727 - FROZEN

experimental: Experimental: PRIM-DJ2727 - CAPSULES

Interventions

PRIM-DJ2727 - FROZEN

Patients with active UC will receive induction dose of 100 grams of stool via frozen retention enema, Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-FROZEN administered in clinic. This consists of microbiota suspension from well-screened donors. Twice filtered fecal microbiota product diluted in saline to 500 mL containing 100g of study drug will be administered as frozen enema induction dose

PRIM-DJ2727 - CAPSULES

Patients with active UC will receive induction dose of 100 grams of stool in orally administered enteric-coated capsules Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-CAPSULES.These capsules consists of microbiota from well-screened donors. The induction dose of enteric-coated capsules will be derived from 100 grams stool.

Primary outcome measure

  • Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC) [ Time Frame: week 5 ]
  • Change in fecal microbiota diversity and genera as assessed by sequencing [ Time Frame: Baseline,end of treatment (4 weeks after baseline) ]
  • Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test [ Time Frame: Baseline,end of treatment (4 weeks after baseline) ]
  • Safety as assessed by the adverse events [ Time Frame: 3 months after last dose ]
  • Safety as assessed by the adverse events [ Time Frame: 6 months after last dose ]

Central Contacts and Locations

Central contacts

Herbert L DuPont, MD

713 500 6687herbert.l.dupont@uth.tmc.edu

Zhi-Dong Jiang, Dr.PH

713 500 9371

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Herbert L DuPont, MD

713-500-9366herbert.l.dupont@uth.tmc.edu

Zhi-Dong Jiang, Dr.PH

713 500 9371zhi-dong.jiang@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 10, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-05-10.