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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 pilot clinical trial to evaluate the safety and feasibility of an oral preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. This study includes adults aged 18 to 75 who have colon polyps, early-stage colorectal cancer (stage I or II), or medically refractory diverticulitis. The research aims to gather initial data on donor microbiota engraftment and its pharmacokinetics to help design future trials for colon and rectal surgery treatments. Participants will receive a suspension of freeze-dried fecal microbiota taken orally after surgery, specifically 48 hours following intravenous antibiotics given at the time of surgery. Prior to surgery, patients will also receive standard bowel preparation and oral antibiotics. The treatment involves a single experimental group receiving MTP-101P, composed of highly purified microbiota from healthy donors. During the trial, participants will provide stool samples that may be mailed in rather than submitted in person. Researchers will monitor the microbiome changes over time, focusing on the engraftment of donor microbiota by analyzing diversity measures until day 180. Participants will have follow-up through telephone, in-person, email, or video visits to comply with study procedures and monitor safety and outcomes throughout the duration of the trial.
CONDITIONS
Brief 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 expected to require adjuvant chemotherapy, or have a history of diverticulitis
- Able to provide fecal samples
- Willing to comply with all study procedures and available for follow-up by telephone, in-person, email, and/or video visits
You will not qualify if you...
- Any history of inflammatory bowel disease such as Crohn's or Ulcerative Colitis
- Pregnancy or breastfeeding; females of child-bearing potential must have a negative pregnancy test before receiving MTP-101P
- Life expectancy less than 6 months
- Presence of ileostomy or colostomy
- Use of immunosuppressants including calcineurin inhibitors, prednisone 20 mg/day or higher, methotrexate, azathioprine, immunosuppressive biologics, or JAK inhibitors
- Neutropenia with absolute neutrophil count less than 0.5 x 10^9 cells/L
- History of solid organ or bone marrow transplant
- Anticipated frequent antibiotic use
- History of severe anaphylactic food allergy
- History of celiac disease
- Receiving cancer chemotherapy, immunotherapy, or radiation
- Unable or unwilling to provide informed consent or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose given 48 hours after IV antibiotics administered during surgery
Participants receive a suspension of freeze-dried microbiota (MTP-101P) after standard pre-surgery preparations and surgery for colon resection.
1 treatment visit (in-person)
Duration - Up to 180 days post-treatment
Participants are monitored for safety and engraftment of donor microbiota with follow-up assessments including fecal samples and microbiome analysis.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
K
Kathryn Vera, PhD
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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