Recruiting

Gut Microbiome & Diet

Sponsor:

Baylor Research Institute

Code:

NCT04751448

Conditions

Colon Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Colon Cancer

Study ID

NCT04751448

Start date

Feb 1, 2021

Status verified date

Jan, 2026

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

11 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection.

Primary outcome measure

  • Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Baylor Research Institute

Recruiting

Temple, Texas, United States, 76508

Contacts

Karen Templeton

254-724-1377karen.templeton@bswhealth.org

Lisa Woytek

254-724-1054lisa.woytek@bswhealth.org

Principal Investigator:

Lucas Wong, MD

More Information

Sponsor

Baylor Research Institute

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • FOLFOX Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-01-26.