[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420185":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":17,"overallOfficials":17,"centralContacts":17,"locations":27,"responsibleParty":61,"collaborators":63,"id":66,"slug":17,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":17,"studyType":79,"phases":17,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":29,"whyStopped":17,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Baylor Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer","Microbiome analysis from at least 112 blinded samples will be conducted from fecal samples to determine sensitivity, specificity and accuracy (reported as percentage) of a microbiome-based predictor of chemotherapy-induced diarrhea in colon cancer.","3 years",[14],{"measure":15,"description":16,"timeFrame":12},"Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer","Dietary analysis from at least 112 blinded surveys will be conducted using food frequency questionnaires (DHQ-III) plus 24 hour recalls collected during treatment to determine sensitivity, specificity and accuracy (reported as percentage) of a dietary-based predictor of chemotherapy-induced diarrhea in colon cancer.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"CASE_ONLY","PROSPECTIVE","In this longitudinal observational study patients will supply samples of their gut microbiome prior to scheduled colonoscopy or surgery along with dietary intake and blood samples; the relative abundance of microbes from those samples along with dietary data will be used to predict the presence or absence and severity of chemotherapy-induced diarrhea. Microbiome and diet based predictions from blinded samples will be combined to map the diet-microbiome changes during treatment to the changes in immune markers and risk of chemotherapy-induced diarrhea.","Colon cancer patient, prior to surgery or prior to treatment start",[24],{"label":25,"type":17,"description":26,"interventionNames":17},"Observational","All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection.",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Temple","Texas","76508","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-97.34278,31.09823,{"lat":39,"lon":38},[42,47,51,54,57,59],{"name":43,"role":44,"phone":45,"phoneExt":17,"email":46},"Karen Templeton","CONTACT","254-724-1377","karen.templeton@bswhealth.org",{"name":48,"role":44,"phone":49,"phoneExt":17,"email":50},"Lisa Woytek","254-724-1054","lisa.woytek@bswhealth.org",{"name":52,"role":53,"phone":17,"phoneExt":17,"email":17},"Lucas Wong, MD","PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},"Hitesh Singh, MD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":17,"phoneExt":17,"email":17},"Juddi Yeh, MD",{"name":60,"role":56,"phone":17,"phoneExt":17,"email":17},"Christal Murray, MD",{"type":62,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[64],{"name":65,"class":6},"Baylor University","100420185",false,"NCT04751448","COLON-MD: Colon Cancer Longitudinal Study","COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment","COLON-MD","Inclusion Criteria:\n\n* Colon cancer diagnosis\n* Age \\>18 and \\\u003C or equal to 79.\n* Ability to perform informed consent\n* FOLFOX treatment expected\n\nExclusion Criteria:\n\n* Not Pregnant\n* Does not have Lynch syndrome or FAP diagnosis.\n* Inability to perform inform consent\n* inability to comply with follow up program\n* history of prior colon cancer diagnosis\n* previous treatment with antibiotics in the last month.\n* previous bowel resection.","ALL","18 Years","79 Years",{"count":77,"type":78},11,"ESTIMATED","OBSERVATIONAL","The goal of this proposal is to identify how the composition of the gut microbiome and diet interact to impact chemotherapy-induced diarrhea incidence and severity.",[82],"Colon Cancer",[84],"FOLFOX Treatment","2026-01-23",{"date":87,"type":88},"2026-01-26","ACTUAL",{"date":90,"type":88},"2021-02-01",{"date":92,"type":78},"2026-06-01",{"name":5,"class":6},1]