Evaluating fecal microbiota transplantation for ulcerative colitis treatment
A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
This study is testing if a new treatment using fecal microbiota transplantation can help people with active ulcerative colitis feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05786404 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, feasibility, and preliminary efficacy of fecal microbiota transplantation (FMT) in patients with active ulcerative colitis (UC). Participants will receive either frozen FMT via retention enema or lyophilized powder in oral capsules as an induction treatment. The study will also analyze changes in the microbiome, including diversity and specific genera, as well as the proportion of antibody-coated microbiota from baseline to post-treatment. The goal is to determine the effectiveness of microbiota replacement therapy in managing active UC.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with active ulcerative colitis who meet specific clinical criteria.
Not a fit: Patients with severe ulcerative colitis or those unable to take retention enemas or capsules may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from active ulcerative colitis.
How similar studies have performed: Other studies have shown promise in using fecal microbiota transplantation for gastrointestinal conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Herbert L DuPont, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Herbert L DuPont, MD
- Email: herbert.l.dupont@uth.tmc.edu
- Phone: 713 500 6687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.