Trials / Recruiting
RecruitingNCT04751448
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 11 (estimated)
- Sponsor
- Baylor Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2021-02-12
- Last updated
- 2026-01-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04751448. Inclusion in this directory is not an endorsement.