Menu
Recruiting NCT07424469

Foregut Leaks-Role of Microbiome

No phase Interventional Gastrointestinal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy and fluid samples.
Who it may be relevant to
Registry conditions: Gastrointestinal Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

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]
  • 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]
Secondary outcome measures (2)
  • Patient demographics [Time frame: Baseline or anytime before surgery]
  • Patient risk of postoperative complications [Time frame: Post surgery until the time leak is healed ( up to 24 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Baylor Scott & White Center for Advanced Surgery — Dallas

Identifiers

NCT: NCT07424469 · 020-307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗