Microbiome in esophageal and stomach leaks
The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07424469 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dallas, Texas
- Baylor Scott & White Center for Advanced Surgery — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Rehma Shabbir
- Email: Rehma.Shabbir@BSWHealth.org
- Phone: 2148201722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.