Actively Recruiting
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
Led by University of Minnesota · Updated on 2025-09-22
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent
- Between 18 and 75 years of age
- Undergoing surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) not needing chemotherapy, or history of diverticulitis
- Able to provide fecal samples
- Willing to comply with all study procedures and available for follow-up by phone, in-person, email, or video
You will not qualify if you...
- Any history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
- Pregnancy or breastfeeding
- Life expectancy less than 6 months
- Presence of ileostomy or colostomy
- Use of immunosuppressant drugs including calcineurin inhibitors, prednisone 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, or JAK inhibitors
- Neutropenia with absolute neutrophil count below 0.5 x 10^9 cells/L
- History of solid organ or bone marrow transplant
- Frequent antibiotic use (such as for recurrent urinary tract infections or sinusitis)
- History of severe anaphylactic food allergy
- History of celiac disease
- Receiving cancer chemotherapy, immunotherapy, or radiation
- Unable or unwilling to give informed consent or follow study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
K
Kathryn Vera, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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