Evaluating fecal microbiota transplantation for ulcerative colitis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.