Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295575
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-02-21
Brief Title:
Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass
Sponsor:
Nanjing Childrens Hospital
Organization:
Nanjing Childrens Hospital
Study Overview
Official Title:
The Effect of Probiotics on Intestinal Barrier Function and Intestinal Flora in Infants With Congenital Heart Disease Undergoing Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2024-02
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:
A randomized controlled study including infants with non-cyanosis congenital heart disease CHD in need of surgical correction involving cardiopulmonary bypass CPB was established Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022 The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo Data concerning patients clinical outcome such as diarrhea were collected Blood samples were collected for measurement of fatty acid binding protein 2 FABP2 diamine oxidase DAO d-lactic acid D-LA and C-reactive protein CRP Stool samples were collected to investigate the changes of intestinal flora
Detailed Description:
None
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