Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment

NCT ID: NCT04751448Sponsor: Baylor Research InstituteLast updated: 2026-01-26

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.

Arms & interventions

Outcome measures

Primary

  • 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

Secondary

  • Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer

    Time frame: 3 years

Eligibility criteria

Sex: AllAge: 18 Years to 79 YearsHealthy volunteers: No
Inclusion Criteria: * Colon cancer diagnosis * Age \>18 and \< or equal to 79. * 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.

Study locations (1)

Baylor Research Institute

Temple, Texas, 76508

Recruiting
Lucas Wong, MD · Principal Investigator
Hitesh Singh, MD · Sub Investigator
Juddi Yeh, MD · Sub Investigator
Christal Murray, MD · Sub Investigator
COLON-MD: Colon Cancer Longitudinal Study | Cancerify