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

NCT04373473 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HSC-MS-20-0316
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adults With Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3

  9 months

Secondary Outcomes (2)

• Quality of life will be characterized by health-related quality of life score.

  9 months

• Subject-reported score in Hospital Anxiety and Depression Scale

  9 months

Study Arms (2)

Patients with UC will receive FMT capsules

EXPERIMENTAL

Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors

Drug: PRIM-DJ2727

Patients with UC will receive placebo

PLACEBO COMPARATOR

Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.

Drug: Placebos

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.

Patients with UC will receive FMT capsules

Placebos DRUG

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

Patients with UC will receive placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥18 years of age
• History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic 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 use an effective method of birth control during the study.
• 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.
• 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.

You may not qualify if:

• Unable to take 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Central Study Contacts

Herbert DuPont, md

CONTACT

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

Zhi-Dong Jiang, Dr.PH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infectious Diseases
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 4, 2020
• Study Start: September 14, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)