COLON-MD: Colon Cancer Longitudinal Study

Colon Cancer Clinical Trial

— COLON-MD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751448
• Other study ID #: 017-342
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2023
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Locations

Country	Name	City	State
United States	Baylor Research Institute	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 years
Secondary	Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer	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