COLON-MD: Colon Cancer Longitudinal Study

This observational study aims to understand how your gut microbiome (the collection of tiny organisms in your intestines) and diet affect chemotherapy-induced diarrhea in people with colon cancer. Researchers will collect samples of your gut microbiome, diet information, and blood samples before your colonoscopy or surgery. They will then use this information to predict if you will experience diarrhea from chemotherapy and how severe it might be. The study is looking for about 11 participants aged 18 to 79 who have been diagnosed with colon cancer and are expected to receive FOLFOX chemotherapy. The study's success will be measured by its ability to predict chemotherapy-induced diarrhea based on microbiome and diet over three years. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 11 participants. It is a longitudinal study, meaning participants will be followed over time.
What's involved
You would provide samples of your gut microbiome, dietary intake information, and blood samples. These samples would be collected prior to your scheduled colonoscopy or surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three years to measure microbiome-based prediction of chemotherapy-induced diarrhea.

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NCT04751448

COLON-MD: Colon Cancer Longitudinal Study

Recruiting
Not specifiedAges 18–79Observational
Baylor Research Institute
~11 participants
Updated 2026-01-26 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
Measured over 3 years
Colon Cancer
1 sites across 1 states
Texas1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Colon cancer diagnosis
Age \>18 and \< or equal to 79.
Ability to perform informed consent
FOLFOX treatment expected

Exclusion

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.
  • Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer3 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.