Actively Recruiting
Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection
Led by University of Minnesota · Updated on 2026-04-03
40
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics).
CONDITIONS
Official Title
Intestinal Microbiota Transplantation 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 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 via telephone, in-person, email, or video visits for the study duration
You will not qualify if you...
- Any history of inflammatory bowel disease
- Pregnant or breastfeeding
- Life expectancy less than 6 months
- Presence of ileostomy or colostomy
- Use of immunosuppressants such as calcineurin inhibitors, prednisone 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, or JAK inhibitors
- Neutropenia (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
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
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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