NCT05786404 Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
| NCT ID | NCT05786404 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Active Ulcerative Colitis (UC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-12-15 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore \>1) * 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 Human Chorionic Gonadotropin(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: * Subjects with sever UC (Mayo score of \>7) * Unable to take retention enema or 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. * Absolute neutrophil count (ANC) \< 500IU/mL
Contact & Investigator
Herbert L DuPont, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05786404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Active Ulcerative Colitis (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05786404 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05786404 currently recruiting?
Yes, NCT05786404 is actively recruiting participants. Contact the research team at herbert.l.dupont@uth.tmc.edu for enrollment information.
Where is the NCT05786404 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05786404 clinical trial?
NCT05786404 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Herbert L DuPont, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 20 participants.
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