Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04104490
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2019-09-24
Brief Title:
Angiotensin Converting Enzyme ACE2 Brain Gut Dysbiosis in Pulmonary Hypertension
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Angiotensin Converting Enzyme ACE2 Brain Gut Dysbiosis in Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2022-10
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:
Pulmonary arterial hypertension PAH is fatal with right heart failure due to raised pulmonary vascular pressure Gut dysbiosis was identified in animals with pulmonary hypertension Deidentified human samples will be tested for gut dysbiosis in PAH circulating bacterial metabolites and markers of inflammation and gut leakiness The gut microbiome and circulating metabolites markers of inflammation and gut leakiness of PAH patients and healthy subjects will be compared in deidentified fecal samples and blood
Detailed Description:
Stool samples will be collected from people with no mild-moderate or severe pulmonary arterial hypertension Bacterial DNA will be extracted from the feces and sequenced by whole genome sequencing shotgun sequencing The DNA sequences will be used to identify the bacteria present in the feces and to model the functions of the gut microbial community in each of the three groups This will test for gut dysbiosis in pulmonary arterial hypertensive patients compared to healthy subjects Gut dysbiosis is a condition where the gut bacterial communities are unbalanced and has been implicated in disease processes
In subjects recruited in the USA blood samples will be tested for markers of gut leakiness and inflammation as well as gut bacterial metabolites found in the circulation
In subjects recruited in the USA blood samples will be tested for markers of gut leakiness and inflammation as well as gut bacterial metabolites found in the circulation
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL102033 | NIH | None | None |
| IRB 16-001964 | OTHER | None | None |
| CAAE 44197015000005327 | OTHER | Federal University of Health Sciences Porto Alegre Brazil | httpsreporternihgovquickSearchR01HL102033 |