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

A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

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.

Study Overview

• Status: Recruiting
• Conditions: Adults With Ulcerative Colitis
• Intervention / Treatment: Drug: PRIM-DJ2727; Drug: Placebos

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Herbert DuPont, md; Phone Number: 713 500 6687; Email: herbert.l.dupont@uth.tmc.edu
• Study Contact Backup: Name: Zhi-Dong Jiang, Dr.PH; Phone Number: 713 500 9371; Email: zhi-dong.jiang@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Herbert L DuPont, MD; Phone Number: 713-500-9366; Email: herbert.l.dupont@uth.tmc.edu
      • Contact: Zhi-Dong Jiang, Dr.PH; Phone Number: 713 500 9371; Email: zhi-dong.jiang@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with UC will receive FMT capsules; Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors	Drug: 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.
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.	Drug: Placebos; Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life will be characterized by health-related quality of life score.		9 months
Subject-reported score in Hospital Anxiety and Depression Scale	After administering 12 weeks of PRIM-DJ2727	9 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Inflammation; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: HSC-MS-20-0316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No