Foregut Leaks-Role of Microbiome

NCT07424469 | Recruiting

• 1 other identifier: 020-307
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Aims

1. 1.To understand the microbial composition involved with foregut leaks
2. 2.To define the virulence changes in the microbiota following foregut leaks
3. 3.To identify host response mechanisms and how they change with interventions
4. 4.Utilize this information to improve patient outcomes

Conditions

Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Patient demographics

  Baseline or anytime before surgery

• Patient risk of postoperative complications

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

Study Arms (1)

Sample collection

OTHER

Samples of microbial fluid and host biopsy taken

Other: Biopsy and fluid samples

Interventions

Biopsy and fluid samples OTHER

Biopsy and fluid samples taken during other medically necessary procedure

Sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an esophageal or stomach leak
• Over 18 years old

You may not qualify if:

• Patients determined by physician/surgeon as not able to tolerate biopsy
• Under 18 years old

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Center for Advanced Surgery

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Rehma Shabbir

CONTACT

2148201722; Rehma.Shabbir@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: February 20, 2026
• Study Start: August 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)