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

NCT ID: NCT04373473

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Patients with UC will receive FMT capsules

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

Group Type: EXPERIMENTAL

PRIM-DJ2727

Intervention Type: 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 placebo

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Herbert DuPont, MD

Professor of Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Herbert DuPont, md

Role: CONTACT

herbert.l.dupont@uth.tmc.edu

713 500 6687

Zhi-Dong Jiang, Dr.PH

Role: CONTACT

zhi-dong.jiang@uth.tmc.edu

713 500 9371

Facility Contacts

Herbert L DuPont, MD

Role: primary

herbert.l.dupont@uth.tmc.edu

713-500-9366

Zhi-Dong Jiang, Dr.PH

Role: backup

zhi-dong.jiang@uth.tmc.edu

713 500 9371

Other Identifiers

HSC-MS-20-0316

Identifier Type: -

Identifier Source: org_study_id