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

Primary Purpose

Adults With Ulcerative Colitis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PRIM-DJ2727

Placebos

About this trial

This is an interventional treatment trial for Adults With Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patients with UC will receive FMT capsules

Patients with UC will receive placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Subject-reported score in Hospital Anxiety and Depression Scale

After administering 12 weeks of PRIM-DJ2727

Full Information

NCT ID

NCT04373473

First Posted

April 28, 2020

Last Updated

March 2, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04373473

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 14, 2020 (Actual)

Primary Completion Date

December 12, 2023 (Anticipated)

Study Completion Date

December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adults With Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with UC will receive FMT capsules

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with UC will receive placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PRIM-DJ2727

Intervention Description

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

Intervention Name(s)

Placebos

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

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

Time Frame

9 months

Title

Subject-reported score in Hospital Anxiety and Depression Scale

Description

After administering 12 weeks of PRIM-DJ2727

Time Frame

9 months

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Herbert DuPont, md

Phone

713 500 6687

herbert.l.dupont@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Zhi-Dong Jiang, Dr.PH

Phone

713 500 9371

zhi-dong.jiang@uth.tmc.edu

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Herbert L DuPont, MD

Phone

713-500-9366

herbert.l.dupont@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Zhi-Dong Jiang, Dr.PH

Phone

713 500 9371

zhi-dong.jiang@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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