This phase I trial tests safety and side effects of freeze-dried microbiota, and evaluates how well it works to restore the presence of good bacteria in the colon (intestinal microbiota) in patients undergoing tissue removal surgery (resection) for stage I-II colon cancer, colon polyps, or diverticulitis. Freeze-dried microbiota is highly purified, freeze-dried intestinal microbiota, gathered from healthy donors' stool. Surgical bowel prep eliminates the harmful bacteria, but it also eliminates the beneficial bacteria that can aid wound healing. Giving freeze dried microbiota may restore the good bacteria in patients undergoing colon resection for stage I-II colon cancer, colon polyps, or diverticulitis.
Additional locations may be listed on ClinicalTrials.gov for NCT06692179.
Locations matching your search criteria
United States
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer CenterStatus: Active
Contact: Cyrus Jahansouz
Phone: 571-251-1456
PRIMARY OBJECTIVE:
I. Evaluate the initial efficacy of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection.
EXPLORATORY OBJECTIVE:
I. To evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152).
OUTLINE:
Patients undergo standard preoperative care including oral (PO) and intravenous (IV) antibiotics and undergo colon resection. Patients then receive MTP-101P PO 48 hours after standard of care IV antibiotics. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed until day 14, then at 30, 60, 90, 120, 150 and 180 days.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorCyrus Jahansouz