Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Microbiome in esophageal and stomach leaks

Official title: The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes

Run by Baylor Research Institute · NCT07424469 · Data updated 2026-11-12

This project will test whether microbes in leaked fluid and nearby tissue from adults with esophageal or stomach leaks differ in ways that affect healing and complications.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorBaylor Research Institute
Academic / other
Locations1 site (Dallas, Texas)
StatusRecruiting
StartedAugust 14, 2020
Main results expectedJuly 1, 2027
Study endsJune 1, 2028
Registry record updatedOctober 15, 2026
Trial IDNCT07424469 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with a diagnosed esophageal or stomach leak who can safely undergo biopsy and fluid sampling are ideal candidates.

Probably not a fit

People under 18, or adults who cannot safely tolerate biopsy procedures, and those without an esophageal or stomach leak are unlikely to benefit from participation.

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

What this trial studies

Investigators will collect infected fluid and tissue biopsy samples from adults who have an esophageal or stomach leak and compare the microbial composition and virulence within and between participants. They will analyze changes in the microbiota that occur with the leak and characterize host response mechanisms from the tissue samples. Comparisons of fluid versus tissue microbiomes will help define which microbial features are associated with worse outcomes or higher risk of postoperative leaks. The results aim to inform preventative approaches and improve patient management after foregut leaks.

Why it matters

Potential benefit: If successful, this work could identify microbial signatures or host responses that help prevent or better treat esophageal and stomach leaks.

How similar studies have gone: Prior work in colorectal anastomotic leaks has linked microbiome changes to poor healing and emerging data suggest a similar role in upper gastrointestinal leaks, but microbiome-guided treatments for foregut leaks remain largely untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with an esophageal or stomach leak
* Over 18 years old

Exclusion Criteria:

* Patients determined by physician/surgeon as not able to tolerate biopsy
* Under 18 years old

Where it's running

  • Baylor Scott & White Center for Advanced Surgery
    Dallas, Texas, United States
    Recruiting

Study contacts

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.