Clinical trial Recruiting at 1 site Observational Ages 18 and up

Gut microbiome and metabolomics after stereotactic radiosurgery

Official title: Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery

Run by University of Chicago · NCT07767981 · Data updated 2026-11-12

This study will see if the gut microbiome and blood metabolites change after stereotactic radiosurgery and whether those changes relate to adverse effects like radiation necrosis.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of Chicago
Academic / other
Drugs / interventionsradiation
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedAugust 5, 2025
Main results expectedAugust 5, 2027
Study endsSeptember 5, 2028
Registry record updatedAugust 18, 2026
Trial IDNCT07767981 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults undergoing stereotactic radiosurgery at the University of Chicago who can provide informed consent.

Probably not a fit

Patients unlikely to benefit are those who do not develop adverse effects or who do not show microbiome/metabolite associations despite participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study follows patients receiving stereotactic radiosurgery as part of standard care, collecting stool and blood samples before treatment and during follow-up. It will profile gut microbiome composition and metabolite patterns over time and compare these with clinical outcomes such as radiation necrosis and other adverse radiation effects. Researchers will also integrate longitudinal imaging and clinical data to explore associations between microbial/metabolite features and adverse events. The goal is to identify potential microbiome-related indicators that could help predict or understand these side effects.

Why it matters

Potential benefit: If successful, findings could help predict which patients are at higher risk for adverse effects based on microbiome or metabolite profiles and guide future interventions.

How similar studies have gone: Prior work has begun to link microbiome profiles with treatment-related toxicities in other radiotherapy settings, but this exact SRS and gut-metabolite focus is exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Admitted to the University of Chicago Medical Center
* Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis
* Able to provide informed consent

Exclusion Criteria:

* Anticipated survival of less than 6 months
* Known or suspected infectious colitis within the month prior to enrollment
* Rectal disease that prevents fecal sampling
* Foreseeable inability to complete the study

Where it's running

  • University of Chicago
    Chicago, Illinois, United States
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.