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

Last updated: May 9, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

1

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

PRIM-DJ2727 - CAPSULES

PRIM-DJ2727 - FROZEN

Clinical Study ID

NCT05786404
HSC-MS-23-0016
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with eachsubscore >1)
  • Sexually active male and female subjects of childbearing potential must agree to usean effective method of birth control during the study.
  • Female subjects of childbearing potential must have a negative urine Qualitative HumanChorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of theTreatment prior to administration of study drug.
  • Willing and able to sign an informed consent form and attend all study-related clinicvisits, assessments, and follow-up phone calls.
  • Subject has an attending physician who will provide the non-FMT care.

Exclusion

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 thestudy.
  • 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, diverticulitisetc.
  • Known history of bile acid diarrhea
  • Compromised immune system (e.g. primary immune disorders or clinical immunosuppressiondue to a medical condition or medication e.g. taking oral prednisone >20 mg a day orprednisone-equivalent)
  • History of active cancer and/or ongoing chemotherapy (superficial non-metastaticcancers 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 studyinvestigator 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 thestudy.
  • Absolute neutrophil count (ANC) < 500IU/mL

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: PRIM-DJ2727 - CAPSULES
Phase: 1
Study Start date:
December 15, 2023
Estimated Completion Date:
December 15, 2027

Study 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.

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

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