NCT06370884 Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection
| NCT ID | NCT06370884 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Minnesota |
| Condition | Recurrent Clostridioides Difficile Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-02-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Cyrus Jahansouz, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06370884 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Recurrent Clostridioides Difficile Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06370884 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06370884 currently recruiting?
Yes, NCT06370884 is actively recruiting participants. Contact the research team at surgcto@umn.edu for enrollment information.
Where is the NCT06370884 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06370884 clinical trial?
NCT06370884 is sponsored by University of Minnesota. The principal investigator is Cyrus Jahansouz, MD at University of Minnesota. The trial plans to enroll 40 participants.