Status:
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
Lead Sponsor:
University of Minnesota
Conditions:
Recurrent Clostridioides Difficile Infection
Colonic Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 pla...
Eligibility Criteria
Inclusion Criteria:
- Able/willing to provide informed consent
- Between 18-75 years of age
- Undergoing surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) not predicted based on pre-operative National Comprehensive Cancer Network guidelines to meet criteria for adjuvant chemotherapy, or a history of diverticulitis.
- Able to provide fecal samples.
- Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence
Exclusion Criteria:
- Any history of inflammatory bowel disease
- Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential on the proposed day of MTP-101P (prior to its administration). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTP-101P.
- Life expectancy of < 6 months
- Presence of ileostomy or colostomy
- Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
- Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
- Patients with neutropenia (an absolute neutrophil count <0.5 x 10^9 cells/L) obtained on a complete blood count with differential at screening.
- History of solid organ or bone marrow transplant.
- Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).
- History of severe anaphylactic food allergy.
- History of celiac disease.
- Patients receiving cancer chemotherapy, immunotherapy, or radiation.
- Subjects who, in the opinion of the Investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
Key Trial Info
Start Date :
February 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 18 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06692179
Start Date
February 18 2025
End Date
February 18 2027
Last Update
September 22 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414