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An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
Sponsor: University of Minnesota
Summary
This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to receive the investigational product. This trial will inform development of future trials in treatment of colon and rectal surgery. Active drug is composed of highly purified, freeze-dried, fecal microbiota from healthy donors. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment. The exploratory objective is to evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152). Stool samples may be returned via mail rather than clinic visit.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-02-18
Completion Date
2027-02-18
Last Updated
2025-09-22
Healthy Volunteers
No
Interventions
Orally administered preparation of fecal microbiota (MTP-101P)
As per standard of care, patients will receive MBP and OA the day prior to surgery as well as IV antibiotics at the time of surgery. MTP-101P will be given 48 hours after the administration of the dose of IV antibiotics to avoid the undesired bactericidal effects of antibiotics on the bacterial load from MTP-101P.
Locations (1)
University of Minnesota
Minneapolis, Minnesota, United States