[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04751448":3,"trial-entities:NCT04751448":92,"trial-summary:NCT04751448":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":38,"minimum_age":39,"maximum_age":40,"healthy_volunteers":15,"eligibility_criteria":41,"std_ages":56,"locations":59,"central_contacts":88,"overall_officials":89,"references":90,"see_also_links":91},"NCT04751448","017-342","COLON-MD: Colon Cancer Longitudinal Study","COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment","RECRUITING","2026-06-01","2026-01","2026-01-26","2021-02-01","Baylor Research Institute","OTHER",false,"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.","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.",[19],"Colon Cancer",[21],"FOLFOX Treatment","OBSERVATIONAL",null,[],{"count":26,"type":27},11,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"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",[35],{"measure":36,"description":37,"timeFrame":33},"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.","ALL","18 Years","79 Years",{"inclusion":42,"exclusion":47,"raw_text":55},[43,44,45,46],"Colon cancer diagnosis","Age \\>18 and \\\u003C or equal to 79.","Ability to perform informed consent","FOLFOX treatment expected",[48,49,50,51,52,53,54],"Not Pregnant","Does not have Lynch syndrome or FAP diagnosis.","Inability to perform inform consent","inability to comply with follow up program","history of prior colon cancer diagnosis","previous treatment with antibiotics in the last month.","previous bowel resection.","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.",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":13,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":85},"Temple","Texas","76508","United States",[66,71,75,78,81,83],{"name":67,"role":68,"phone":69,"email":70},"Karen Templeton","CONTACT","254-724-1377","karen.templeton@bswhealth.org",{"name":72,"role":68,"phone":73,"email":74},"Lisa Woytek","254-724-1054","lisa.woytek@bswhealth.org",{"name":76,"role":77},"Lucas Wong, MD","PRINCIPAL_INVESTIGATOR",{"name":79,"role":80},"Hitesh Singh, MD","SUB_INVESTIGATOR",{"name":82,"role":80},"Juddi Yeh, MD",{"name":84,"role":80},"Christal Murray, MD",{"lat":86,"lon":87},31.09823,-97.34278,[],[],[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Colon Carcinoma",[],{"nct_id":4,"found":97,"summary":98,"prompt_version":107},true,{"design":99,"status":100,"heading":6,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an observational study with a planned enrollment of 11 participants. It is a longitudinal study, meaning participants will be followed over time.","completed","This observational study aims to understand how your gut microbiome (the collection of tiny organisms in your intestines) and diet affect chemotherapy-induced diarrhea in people with colon cancer. Researchers will collect samples of your gut microbiome, diet information, and blood samples before your colonoscopy or surgery. They will then use this information to predict if you will experience diarrhea from chemotherapy and how severe it might be. The study is looking for about 11 participants aged 18 to 79 who have been diagnosed with colon cancer and are expected to receive FOLFOX chemotherapy. The study's success will be measured by its ability to predict chemotherapy-induced diarrhea based on microbiome and diet over three years. The current recruitment status is unclear.","Participants will be followed for three years to measure microbiome-based prediction of chemotherapy-induced diarrhea.",120,"You would provide samples of your gut microbiome, dietary intake information, and blood samples. These samples would be collected prior to your scheduled colonoscopy or surgery.","Not stated in the trial record.",[],"v2"]