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NCT06370884

Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

Recruiting
PHASE1Ages 18–75Interventional
University of Minnesota
~40 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:IMT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate safety of IMT in patients undergoing colon surgery
Measured over Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180
+1 more outcome measured

Conditions

Recurrent Clostridioides Difficile Infection
Colonic Surgery

Explore related trials

Clostridium difficile InfectionDiverticulitisMalignant Sigmoid Colon Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Cyrus Jahansouz, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Surgery Clinical Trials Office
[email protected]
612-624-7463
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Evaluate safety of IMT in patients undergoing colon surgeryDay of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180

    Collected via adverse event monitoring, to be reported as frequency, relatedness, expectedness, and severity of AEs/SAEs

  • compare fecal microbiota prior to and after IMTDay -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180

    Collected via stool sample collection, to be reported as sequenced microbial DNA profiles (alpha diversity, beta diversity)