protocolSection identificationModule nctId: NCT06370884, orgStudyIdInfo id: SURG-2023-29833, briefTitle: Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: 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 will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT or a saline 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 or saline, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT/saline, 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)., conditionsModule conditions: Recurrent Clostridioides Difficile Infection, conditions: Colonic Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients undergoing colon resection., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The study will be double-blinded; assignments of study staff to either the blinded or unblinded team will be made in advance of enrollment of the first study participant and will be recorded as such on regulatory documents (e.g., blinded/unblinded DOA)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: IMT, interventions name: Saline solution, outcomesModule primaryOutcomes measure: Evaluate safety of IMT in patients undergoing colon surgery, primaryOutcomes measure: compare fecal microbiota prior to and after IMT, secondaryOutcomes measure: Evaluate engraftment of donor microbiota, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: WBC, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: Hemoglobin, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: Platelets, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: Electrolytes, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation, secondaryOutcomes measure: Evaluate changes in circulating markers of inflammation: alkaline phosphatase, secondaryOutcomes measure: Evaluate changes in circulating markers: Albumin, secondaryOutcomes measure: Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids, secondaryOutcomes measure: Evaluate changes in microbial metabolites: Fecal IgA, secondaryOutcomes measure: Compare baseline microbiome characteristics with changes over time after IMT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Kathryn Vera, PhD, role: CONTACT, phone: 612-625-5018, email: giero002@umn.edu, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False