NCT04751448

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2021Jun 2026

Study Start

First participant enrolled

February 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5.3 years

First QC Date

February 2, 2021

Last Update Submit

January 23, 2026

Conditions

Colon Cancer

Keywords

FOLFOX Treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer

    3 years

Study Arms (1)

Observational

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

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Colon cancer patient, prior to surgery or prior to treatment start

You may qualify if:

  • Colon cancer diagnosis
  • Age \>18 and \< or equal to 79.
  • Ability to perform informed consent
  • FOLFOX treatment expected

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Research Institute

Temple, Texas, 76508, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample kit, Tissue at time of surgery, blood draw(2 vials) at specific times up to 5 times.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 12, 2021

Study Start

February 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

US(1)