An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06692179
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Colonic Surgery
  • Recurrent Clostridioides Difficile Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Orally administered preparation of fecal microbiota (MTP-101P) — DRUG
    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.

Study Details

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 Dates

Start date
Feb 18, 2025
Status verified
Sep 2025
Primary completion
Feb 18, 2027
Completion
Feb 18, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Experimental group
    Male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis.

Primary Outcome Measure

Evaluate engraftment of donor microbiota (see 15.3 for statistics) via determination of alpha and beta diversity. [ Time Frame: Day180 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Kathryn Vera

Find similar trials in Minneapolis, MN

By research site
University of Minnesota· Minneapolis, MN

Related Studies