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

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.

Conditions

Active Ulcerative Colitis (UC)

Study Overview

Study Details

Study overview

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.

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

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

Condition
Active Ulcerative Colitis (UC)
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-12-15