RECRUITING

Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

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Conditions

Active Ulcerative Colitis (UC)

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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 study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.

Official Title

A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

Quick Facts

Study Start:2023-12-15
Study Completion:2027-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05786404

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 CriteriaExclusion Criteria
  1. * Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore \>1)
  2. * Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
  3. * Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
  4. * Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
  5. * Subject has an attending physician who will provide the non-FMT care.
  1. * Subjects with sever UC (Mayo score of \>7)
  2. * Unable to take retention enema or multiple capsules orally.
  3. * Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
  4. * Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
  5. * Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
  6. * History of recurrent Clostridium difficile infection or FMT in the past 6-months.
  7. * 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.
  8. * Known history of bile acid diarrhea
  9. * 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)
  10. * History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
  11. * History of use of an investigational drug within 90 days prior to the screening visit.
  12. * History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
  13. * Life expectancy of \< 1 year.
  14. * In the opinion of investigator, subject for any reason, should be excluded from the study.
  15. * Absolute neutrophil count (ANC) \< 500IU/mL

Contacts and Locations

Study Contact

Herbert L DuPont, MD
CONTACT
713 500 6687
herbert.l.dupont@uth.tmc.edu
Zhi-Dong Jiang, Dr.PH
CONTACT
713 500 9371

Principal Investigator

Herbert L DuPont, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

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

  • Herbert L DuPont, MD, PRINCIPAL_INVESTIGATOR, 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 Date2023-12-15
Study Completion Date2027-12-15

Study Record Updates

Study Start Date2023-12-15
Study Completion Date2027-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • Active Ulcerative Colitis (UC)