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NCT Number: NCT04751448

COLON-MD: Colon Cancer Longitudinal Study

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor Research Institute

Temple, Texas, 76508, United States

Location status: Recruiting

Location contact

Christal Murray, MD

SUB_INVESTIGATOR

Hitesh Singh, MD

SUB_INVESTIGATOR

Juddi Yeh, MD

SUB_INVESTIGATOR

Karen Templeton

CONTACT

[email protected]

254-724-1377

Lisa Woytek

CONTACT

[email protected]

254-724-1054

Lucas Wong, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Baylor University

Registry information

Official study title

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

Acronym: COLON-MD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2021
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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