Observational Study of Gut Microbiome and Cancer-Related Symptoms

This study is looking at how the gut microbiome (the community of bacteria and other tiny organisms in your intestines) might be connected to cancer-related fatigue and cognitive impairment (CRCI), which is a decrease in thinking abilities. Researchers will collect information from 250 people with cancer to understand the makeup of their gut microbiome. They will also assess fatigue and thinking abilities. The goal is to see if there are common patterns in the gut microbiome that are linked to these symptoms across different types of cancer and treatments. You can join if you are 18 or older, have a cancer diagnosis, and have internet access. This is an observational study, meaning you won't receive any new treatments.

Study design
This is an observational study planning to enroll 250 participants. It is not a treatment study, but rather aims to collect information.
What's involved
Participants will provide fecal samples at the beginning of the study and again at 6 months. They will also be assessed for fatigue and cognitive impairment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the initial assessment.

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NCT06098404

Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

Recruiting
Not specifiedAges 18+Observational
The University of Texas Medical Branch, Galveston
~250 participants
Updated 2025-12-16 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterization of fecal microbiome using molecular methods at baseline
Measured over Baseline
+1 more outcome measured
Cancer
1 sites across 1 states
Texas1
  • Melinda Sheffield-Moore, PhD · PRINCIPAL_INVESTIGATOR · University of Texas

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  • Characterization of fecal microbiome using molecular methods at baselineBaseline

    Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline

  • Characterization of fecal microbiome using molecular methods at 6 months6 months

    Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR after 6 months of standard of care treatment.