Transplanting gut bacteria in patients after colon surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label Phase 1 study assessing the safety and feasibility of intestinal microbiota transplantation (IMT) in patients undergoing colonic surgery. Participants aged 18-75 with a history of diverticulitis or sigmoid colon cancer will receive an IMT solution via a nasogastric feeding tube on postoperative days 2-3, following a course of intravenous antibiotics. The study involves screening for eligibility, collecting baseline blood and fecal samples, and monitoring participants for compliance and safety throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* 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 IMT (prior to the receipt of IMT). 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 IMT treatment.
* 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 109 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.

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Cyrus Jahansouz, MD — University of Minnesota
• Study coordinator: Surgery Clinical Trials Office
• Email: surgcto@umn.edu
• Phone: 612-624-7463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.