Recruiting
Phase 1

Microbiota Transplantation

Sponsor:

University of Minnesota

Code:

NCT06370884

Conditions

Recurrent Clostridioides Difficile Infection

Colonic Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IMT

Study Details

Brief summary:

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

Recurrent Clostridioides Difficile Infection

Colonic Surgery

Study ID

NCT06370884

Start date

Feb 1, 2024

Status verified date

Sep, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: IMT group

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 either IMT solution

Interventions

IMT

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.

Primary outcome measure

  • Evaluate safety of IMT in patients undergoing colon surgery [ Time Frame: Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180 ]
  • compare fecal microbiota prior to and after IMT [ Time Frame: Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180 ]

Central Contacts and Locations

Central contacts

Surgery Clinical Trials Office

612-624-7463surgcto@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Surgery Clinical Trials Office

612-624-7463surgcto@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-03.