RECRUITING

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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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-09-14

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04373473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

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 Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-14

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-09-14

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Adults With Ulcerative Colitis