Clinical trial NCT05786404: Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Official title: A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Active Ulcerative Colitis (UC)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.

Eligibility 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

Primary outcomes:
measure: Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
timeFrame: week 5
measure: Change in fecal microbiota diversity and genera as assessed by sequencing
timeFrame: Baseline,end of treatment (4 weeks after baseline)
measure: Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
timeFrame: Baseline,end of treatment (4 weeks after baseline)
measure: Safety as assessed by the adverse events
timeFrame: 3 months after last dose
measure: Safety as assessed by the adverse events
timeFrame: 6 months after last dose
Secondary outcomes:
measure: Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
timeFrame: baseline, week 5, early termination(if applicable)
measure: Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, week 5, early termination(if applicable)
measure: Change in fecal microbiota diversity and genera as assessed by sequencing
timeFrame: Baseline,end of treatment (4 weeks after baseline), 6 months
measure: Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing
timeFrame: Baseline,end of treatment (4 weeks after baseline), 6 months follow up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Herbert L DuPont, MD
role: PRINCIPAL_INVESTIGATOR
References: