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NCT04751448 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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