COLON-MD: Colon Cancer Longitudinal Study (COLON-MD)

January 23, 2026 updated by: Baylor Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Research Institute
        • Principal Investigator:
          • Lucas Wong, MD
        • Contact:
        • Sub-Investigator:
          • Hitesh Singh, MD
        • Sub-Investigator:
          • Juddi Yeh, MD
        • Sub-Investigator:
          • Christal Murray, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Colon cancer patient, prior to surgery or prior to treatment start

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observational
All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Baylor University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017-342

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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