An observational study in Colon Cancer, sponsored by Baylor Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Baylor Research Institute · 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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 11 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
Colon cancer patient, prior to surgery or prior to treatment start
Exclusion Criteria:
All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection.
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.
Time frame: 3 years
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.
Time frame: 3 years
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