Foregut Leaks-Role of Microbiome

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

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

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Other: Biopsy and fluid samples

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rehma Shabbir; Phone Number: 2148201722; Email: Rehma.Shabbir@BSWHealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White Center for Advanced Surgery
      • Contact: Rehma Shabbir; Phone Number: 214-820-1722; Email: Rehma.Shabbir@BSWHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sample collection; Samples of microbial fluid and host biopsy taken	Other: Biopsy and fluid samples; Biopsy and fluid samples taken during other medically necessary procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial composition of samples	change in virulence factors, microbial response to treatment modalities	During the surgery
Time of healing of leaks	Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation.	From index intervention until documented leak resolution ( up to 24 weeks)
Proportion of patients achieving leak closure without need for additional surgical intervention	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.	Up to 24 weeks post-surgery
Incidence of postoperative complications	Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded.	Within 30 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics	age, sex, race, ethnicity	Baseline or anytime before surgery
Patient risk of postoperative complications	Calculated by ACS risk calculator	Post surgery until the time leak is healed ( up to 24 weeks)

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: 020-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No