Actively Recruiting
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Led by The University of Texas Health Science Center, Houston · Updated on 2024-05-10
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of active Ulcerative Colitis with Partial Mayo score of 3 or higher and each subscore above 1
- Sexually active men and women of childbearing potential must agree to use effective birth control during the study
- Female participants of childbearing potential must have negative urine pregnancy test at enrollment and before treatment
- Willing and able to sign informed consent and attend all study visits, assessments, and follow-ups
- Have an attending physician to provide non-FMT care
You will not qualify if you...
- Severe Ulcerative Colitis with Mayo score above 7
- Unable to receive retention enema or multiple oral capsules
- Pregnant, breastfeeding, or planning pregnancy during the study
- Received systemic non-topical antibiotics within 14 days before treatment
- Positive for active HIV, Hepatitis B, or Hepatitis C infections
- History of recurrent Clostridium difficile infection or FMT in past 6 months
- Other active gastrointestinal diseases like irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, fistulae or strictures, chronic parasitic infections, diverticulitis
- Known bile acid diarrhea
- Compromised immune system or taking oral prednisone over 20 mg daily
- History of active cancer or ongoing chemotherapy (except superficial non-metastatic cancers and maintenance chemotherapy)
- Use of investigational drug within 90 days before screening
- Significant uncontrolled systemic disease interfering with participation
- Life expectancy less than 1 year
- Absolute neutrophil count below 500 IU/mL
- Any other condition deemed exclusionary by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Herbert L DuPont, MD
CONTACT
Z
Zhi-Dong Jiang, Dr.PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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