[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505358":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inulin group","EXPERIMENTAL","Patients randomized to the intervention group will receive inulin supplementation for 14 days, preceding the surgery. Inulin will be given at a dosage of 10g\u002Fday divided in two doses.",[13],"Dietary Supplement: Inulin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Patients randomized to the control group will receive a placebo for 14 days, two times a day.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Inulin","Inulin is a water soluble non-digestible carbohydrate, and it is available in more than 36,000 species of plants. It is often used as dietary fiber and has obtained the \"Generally recognized as safe\" status (GRAS) by the Food and Drug Administration (FDA).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo control",[15],[32],{"name":33,"affiliation":5,"role":34},"Carole Richard, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","514 890-8000","carole.richard.med@ssss.gouv.qc.ca",{"name":41,"role":37,"phone":38,"phoneExt":42,"email":43},"Nassima Taleb","10812","nassima.taleb.chum@ssss.gouv.qc.ca",[45],{"facility":5,"status":26,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Montreal","Quebec","H2X 3E4","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-73.58781,45.50884,{"lat":55,"lon":54},[58],{"name":33,"role":37,"phone":59,"phoneExt":26,"email":39},"514-890-8000",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100505358","the-effect-of-inulin-supplementation-on-colorectal-surgery-outcomes-100505358",false,"NCT05860322","The Effect of Inulin Supplementation on Colorectal Surgery Outcomes","The Effect of Inulin Supplementation on Colonic Healing and Surgical Outcomes Following Colorectal Surgery","INULINE","Inclusion Criteria:\n\n* Patients with a colorectal cancer and who present for elective colorectal surgery\n\nExclusion Criteria:\n\n* Emergency surgery for perforation\u002Fobstruction.\n* Use of antibiotics within 4 weeks prior to surgery (other than usual antibiotic prophylaxis).\n* Presence of preoperative ileostomy or colostomy.\n* Intestinal surgery within 4 weeks prior to colonic surgery.\n* Active asthma.\n* Presence of familial adenomatous polyposis.","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"NA","Colorectal cancer (CRC) is the third most diagnosed cancer in Canada. The most common surgical procedure in patients with CRC is an intestinal resection followed by a reconnection to rejoin the ends of the remaining bowel. Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized by impaired intestinal healing and are associated with severe infections and even death.\n\nVarious studies have shown that gut microbiota, the bacteria that live in the digestive tract, plays an essential role in intestinal healing following surgery. These results support the possibility of enhancing intestinal healing through supplements that act as an energy source for gut bacteria. Indeed, animal studies have shown that inulin supplementation, a fiber commonly found in plants, improves intestinal healing following bowel surgery. However, no studies in humans have evaluated its effects on CRC surgery patients.\n\nThis study aims to determine feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery.",[80],"Anastomotic Complication",[82,83,84,85],"colorectal cancer","inuline","anastomotic leak","anastomotic healing","NOT_YET_RECRUITING","2023-05-05",{"date":89,"type":90},"2023-05-16","ACTUAL",{"date":92,"type":74},"2023-08-01",{"date":94,"type":74},"2028-08-01",{"name":5,"class":6},1]