Recruiting

Microbial Composition

Sponsor:

Baylor Research Institute

Code:

NCT07424469

Conditions

Gastrointestinal Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy and fluid samples

Study Details

Brief summary:

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

Conditions

Gastrointestinal Diseases

Study ID

NCT07424469

Start date

Aug 14, 2020

Status verified date

Nov, 2025

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Sample collection

Samples of microbial fluid and host biopsy taken

Interventions

Biopsy and fluid samples

Biopsy and fluid samples taken during other medically necessary procedure

Primary outcome measure

  • Microbial composition of samples [ Time Frame: During the surgery ]
  • Time of healing of leaks [ Time Frame: From index intervention until documented leak resolution ( up to 24 weeks) ]
  • Proportion of patients achieving leak closure without need for additional surgical intervention [ Time Frame: Up to 24 weeks post-surgery ]
  • Incidence of postoperative complications [ Time Frame: Within 30 days post-surgery ]

Central Contacts and Locations

Central contacts

Rehma Shabbir

2148201722Rehma.Shabbir@BSWHealth.org

Locations

Baylor Scott & White Center for Advanced Surgery

Recruiting

Dallas, Texas, United States, 75246

Contacts

Rehma Shabbir

214-820-1722Rehma.Shabbir@BSWHealth.org

More Information

Sponsor

Baylor Research Institute

Last update posted

Feb 20, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-02-20.