Colon cancer longitudinal: how gut microbes and diet relate to chemotherapy-related diarrhea
COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
This project will try to see if patterns in the gut microbiome and patients' diets can predict which adults with colon cancer receiving FOLFOX will get chemotherapy-related diarrhea and how severe it will be.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 11 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Temple, Texas) |
| Trial ID | NCT04751448 on ClinicalTrials.gov |
What this trial studies
This longitudinal observational project enrolls adults with colon cancer scheduled to receive FOLFOX and collects stool samples, dietary records, and blood samples before treatment and during follow-up. Researchers will sequence the gut microbiome to determine relative abundances of microbes and combine these data with detailed dietary intake and immune marker measurements. Blinded analyses will develop and test models to predict the presence and severity of chemotherapy-induced diarrhea based on microbiome and diet features. The study will also map how diet and microbiome change during treatment and how those changes relate to immune markers and diarrhea risk.
Who should consider this trial
Good fit: Adults aged 18–79 with a diagnosis of colon cancer who are planning to receive FOLFOX, can give informed consent, and can provide stool, dietary, and blood samples are ideal candidates.
Not a fit: People who are pregnant, have Lynch syndrome or FAP, have had recent antibiotic use or prior bowel resection, cannot comply with follow-up, or are not receiving FOLFOX are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could help identify patients at high risk for FOLFOX-related diarrhea and support personalized diet or microbiome-based strategies to prevent or reduce symptoms.
How similar studies have performed: Prior research has linked gut microbiome composition to chemotherapy side effects and some studies suggest diet influences toxicity, but using combined diet-microbiome prediction for FOLFOX diarrhea is a relatively new and emerging approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Temple, Texas
- Baylor Research Institute — Temple, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.