NCT07424469 · Baylor Research Institute
Foregut Leaks-Role of Microbiome
What this study is about
Aims 1. To understand the microbial composition involved with foregut leaks 2. To define the virulence changes in the microbiota following foregut leaks 3. To identify host response mechanisms and how they change with interventions 4.
View original scientific description
Aims 1. To understand the microbial composition involved with foregut leaks 2. To define the virulence changes in the microbiota following foregut leaks 3. To identify host response mechanisms and how they change with interventions 4.
Interventions
OTHER
Biopsy and fluid samples
Biopsy and fluid samples taken during other medically necessary procedure
Primary outcome measures
Microbial composition of samples
Time frame: During the surgery
change in virulence factors, microbial response to treatment modalities
Time of healing of leaks
Time frame: From index intervention until documented leak resolution ( up to 24 weeks)
Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation.
Proportion of patients achieving leak closure without need for additional surgical intervention
Time frame: Up to 24 weeks post-surgery
Successful endoscopic management will be defined as complete leak resolution without requirement for subsequent operative surgical repair. This will be measured as a percentage of participants.
Incidence of postoperative complications
Time frame: Within 30 days post-surgery
Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations