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โ† Trials
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Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

RecruitingPhase 1Ages 18 Years - 75 YearsAllUniversity of Minnesota
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In plain words

What the trial is, and whether it could suit you

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 mecha

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • IMT
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Where

1 site
University of Minnesota
Minneapolis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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