NCT05786404RecruitingPhase 1
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 10 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 13 Mar 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- Ulcerative colitis
- NCT number
- NCT05786404
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 15 Dec 2023 to the primary completion date, 15 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of use of an investigational drug within 90 days prior to the screening visit.
Other illness
- 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 significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
Lab values
- Absolute neutrophil count (ANC) \< 500IU/mL
Other
- 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.
- Life expectancy of \< 1 year.
- In the opinion of investigator, subject for any reason, should be excluded from the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.