Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:36 PM
Study NCT ID:
NCT07424469
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foregut Leaks-Role of Microbiome
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: