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

Conditions

• Adults With Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PRIM-DJ2727 — DRUG
  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 — DRUG
  Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.

Study Details

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.

Key Dates

Start date

Sep 14, 2020

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

58 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Patients with UC will receive FMT capsules
  Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors
• Placebo Comparator: Patients with UC will receive placebo
  Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.

Primary Outcome Measure

Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3 [ Time Frame: 9 months ]

Central Contacts

• Herbert DuPont, md
  713 500 6687
  [email protected]
• Zhi-Dong Jiang, Dr.PH
  713 500 9371
  [email protected]

Locations (1)

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