Transplanting gut bacteria in patients after colon surgery

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection

This study is testing if giving gut bacteria to patients after colon surgery can help them recover safely and effectively.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Minnesota (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, methotrexate, prednisone
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT06370884 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 undergoing surgery for diverticulitis or sigmoid colon cancer.

Not a fit: Patients with inflammatory bowel disease or those on immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the recurrence of Clostridioides difficile infections in patients post-colon surgery.

How similar studies have performed: While the approach of IMT is gaining interest, this specific application in post-colon surgery patients is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Cyrus Jahansouz, MD — University of Minnesota
• Study coordinator: Kathryn Vera

Conditions: Recurrent Clostridioides Difficile Infection, Colonic Surgery