COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Observational
- Conditions
- Colon Cancer
- Sponsor
- Baylor Research Institute
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Colon cancer diagnosis
- •Age \>18 and \< or equal to
- •Ability to perform informed consent
- •FOLFOX treatment expected
Exclusion Criteria
- •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.
Arms & Interventions
Observational
All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection.
Outcomes
Primary Outcomes
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
Time Frame: 3 years
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.
Secondary Outcomes
- Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer(3 years)