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NCT Number: NCT07424469

Foregut Leaks-Role of Microbiome

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. Utilize this information to improve patient outcomes

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White Center for Advanced Surgery

Dallas, Texas, 75246, United States

Location status: Recruiting

Location contact

Rehma Shabbir

CONTACT

[email protected]

214-820-1722

About this study

For this study, investigators will compare the microbial composition of the infected fluid from the leak to that of a tissue sample taken from the participant. This will allow investigators to compare the composition and virulence of the microbiome both within and between participants. These comparisons will help further the understanding of the pathogenesis of these leaks, as well as identify which participants may be most at risk of developing postoperative leaks. The combination of this information has the potential to contribute to the development of preventative measures and improve patient outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy and fluid samples

Other

Biopsy and fluid samples taken during other medically necessary procedure

Primary outcomes

  1. Microbial composition of samples

    Time frame: During the surgery

    change in virulence factors, microbial response to treatment modalities

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Patient demographics

    Time frame: Baseline or anytime before surgery

    age, sex, race, ethnicity

  2. Patient risk of postoperative complications

    Time frame: Post surgery until the time leak is healed ( up to 24 weeks)

    Calculated by ACS risk calculator

Study contacts

Contact information is provided by the study sponsor or research team.

Rehma Shabbir

CONTACT

[email protected]

2148201722

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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