Actively Recruiting
An Open-Label Pilot Trial Testing Safety and Feasibility of Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection
Led by University of Minnesota · Updated on 2026-04-03
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of intestinal microbiota transplantation (IMT) in patients undergoing colon surgery, specifically those with a history of diverticulitis or sigmoid colon cancer. This open-label pilot study focuses on adults aged 18 to 75 and aims to understand how IMT affects the gut microbiome and inflammation after surgery. The study is conducted by the University of Minnesota and involves detailed monitoring of participants to assess potential risks and changes over time. Participants will have a feeding tube placed during their colon surgery, and the IMT solution will be administered through this tube on postoperative days 2 to 3, after at least 48 hours following intravenous antibiotics. The feeding tube will then be removed. The study uses a nasogastric feeding tube placed under anesthesia to reduce risks associated with colonoscopic procedures. This single treatment phase includes in-patient monitoring and extends to follow-up visits and sample collections over several months. During the study, participants will provide baseline blood and fecal samples before receiving IMT, followed by multiple sample collections and health assessments up to six months post-treatment. Researchers will monitor safety through interviews, symptom questionnaires, and clinical evaluations, screening for adverse events regularly after surgery and during follow-ups. The primary outcomes include safety assessment and comparison of fecal microbiota before and after IMT. Secondary outcomes involve evaluating inflammation markers and microbiome changes at scheduled intervals across the study timeline.
CONDITIONS
Brief Title
Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able/willing to provide informed consent
- Between 18-75 years of age
- Undergoing surgery for a history of diverticulitis or sigmoid colon cancer
- Able to provide fecal samples
- Willing to comply with all study procedures and available for follow-up by phone, in-person, email, or video visits
You will not qualify if you...
- Any history of inflammatory bowel disease
- Pregnancy or breastfeeding
- Life expectancy less than 6 months
- Presence of ileostomy or colostomy
- Use of immunosuppressants such as calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, or JAK inhibitors
- Neutropenia with absolute neutrophil count less than 0.5 x 10⁹ cells/L
- History of solid organ or bone marrow transplant
- Anticipated recurrent antibiotic use
- History of severe anaphylactic food allergy
- History of celiac disease
- Receiving cancer chemotherapy, immunotherapy, or radiation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and postoperative days 1 to 3
Participants undergo colon resection surgery during which a feeding tube is placed. On postoperative day 2 to 3, participants receive the intestinal microbiota transplantation (IMT) solution through the feeding tube, which is then removed.
1 surgery visit and up to 3 postoperative visits (in-person)
Duration - Up to 180 days after surgery
Participants are monitored for safety and changes in microbiota and inflammatory markers through multiple assessments after surgery and IMT.
Multiple follow-up visits at Day 14, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180 (in-person or remote)
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
K
Kathryn Vera
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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