Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05786404
Phase
PHASE1
Status
Recruiting
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Conditions

  • Active Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PRIM-DJ2727 - FROZEN — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
May 2024
Primary completion
Dec 15, 2026
Completion
Dec 15, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: PRIM-DJ2727 - FROZEN
  • Experimental: Experimental: PRIM-DJ2727 - CAPSULES

Primary Outcome Measure

Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC) [ Time Frame: week 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Herbert L DuPont, MD
[email protected]
713-500-9366
Zhi-Dong Jiang, Dr.PH
[email protected]
713 500 9371

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The University of Texas Health Science Center at Houston· Houston, TX