Colon CancerCOLON-MDNCT04751448
COLON-MD: Colon Cancer Longitudinal Study
An observational study of Colon Cancer, run by Baylor Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colon Cancer
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 15 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colon cancer patient, prior to surgery or prior to treatment start
Who may be able to join
- Colon cancer diagnosis
- Age >18 and < or equal to 79.
- Ability to perform informed consent
- FOLFOX treatment expected
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
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.
Read the 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
- Colon Cancer
- Keywords
- FOLFOX Treatment
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Feb 2021
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751448
- Sponsor's protocol ID
- 017-342
- Acronym
- COLON-MD
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
- ClinicalTrials.gov ID
- NCT04751448
- Acronym / sponsor ID
- COLON-MD / 017-342
- Conditions
- Colon Cancer
- Keywords
- FOLFOX Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Baylor University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colon cancer patient, prior to surgery or prior to treatment start
Key inclusion criteria (4 listed)
- Colon cancer diagnosis
- Age >18 and < or equal to 79.
- Ability to perform informed consent
- FOLFOX treatment expected
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
Time frame: 3 years
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.
1 secondary outcome
Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.