COLON-MD: Colon Cancer Longitudinal Study

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04751448

Acronym

COLON-MD

Enrollment

Registered

2021-02-12

Start date

2021-02-01

Completion date

2026-06-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

FOLFOX Treatment

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer	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

Measure	Time frame	Description
Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer	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.

Countries

United States

Outcome results