[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-clostridioides-difficile-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-clostridioides-difficile-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100569279","phase-1-an-open-label-pilot-clinical-trial-to-test-the-safety-and-feasibility-of-a-suspension-of-freeze-dried-microbiota-in-patients-undergoing-colon-resection-100569279",false,"NCT06692179","An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection","Inclusion Criteria:\n\n* Able\u002Fwilling to provide informed consent\n* Between 18-75 years of age\n* Undergoing surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) not predicted based on pre-operative National Comprehensive Cancer Network guidelines to meet criteria for adjuvant chemotherapy, or a history of diverticulitis.\n* Able to provide fecal samples.\n* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and\u002For video visits or correspondence\n\nExclusion Criteria:\n\n* Any history of inflammatory bowel disease\n* Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential on the proposed day of MTP-101P (prior to its administration). 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 MTP-101P.\n* Life expectancy of \\\u003C 6 months\n* Presence of ileostomy or colostomy\n* Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)\n* Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg\u002Fday, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).\n* Patients with neutropenia (an absolute neutrophil count \\\u003C0.5 x 10\\^9 cells\u002FL) obtained on a complete blood count with differential at screening.\n* History of solid organ or bone marrow transplant.\n* Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).\n* History of severe anaphylactic food allergy.\n* History of celiac disease.\n* Patients receiving cancer chemotherapy, immunotherapy, or radiation.\n* Subjects who, in the opinion of the Investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.","ALL","18 Years","75 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to receive the investigational product. This trial will inform development of future trials in treatment of colon and rectal surgery. Active drug is composed of highly purified, freeze-dried, fecal microbiota from healthy donors. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment. The exploratory objective is to evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152). Stool samples may be returned via mail rather than clinic visit.",[26,27],"Recurrent Clostridioides Difficile Infection","Colonic Surgery","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2025-02-18",{"date":36,"type":20},"2027-02-18",{"name":38,"class":39},"University of Minnesota","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":40},"100544591","phase-1-intestinal-microbiota-transplantation-in-patients-undergoing-colon-resection-100544591","NCT06370884","Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection","An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection","Inclusion Criteria:\n\n* Able\u002Fwilling to provide informed consent\n* Between 18-75 years of age\n* Undergoing surgery for a history of diverticulitis or sigmoid colon cancer.\n* Able to provide fecal samples\n* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and\u002For video visits or correspondence\n\nExclusion Criteria:\n\n* Any history of inflammatory bowel disease\n* 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.\n* Life expectancy of \\\u003C 6 months\n* Presence of ileostomy or colostomy\n* Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)\n* Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg\u002Fday, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)\n* Patients with neutropenia (an absolute neutrophil count \\\u003C 0.5 x 109 cells\u002FL) obtained on a complete blood count with differential at screening.\n* History of solid organ or bone marrow transplant.\n* Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).\n* History of severe anaphylactic food allergy.\n* History of celiac disease.\n* Patients receiving cancer chemotherapy, immunotherapy, or radiation.",{"count":19,"type":20},[23],"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\u002Fexclusion 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).",[26,27],{"date":31,"type":32},{"date":54,"type":32},"2024-02-01",{"date":56,"type":20},"2026-09-01",{"name":38,"class":39}]