Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730777
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-16
First Post:
2023-02-06
Brief Title:
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection The investigators will also explore prevention and treatment through randomized controlled trials to initiate early intervention before clinical symptoms appear
Detailed Description:
This is a single-center randomized controlled trial in which 100 patients treated with antineoplastic agents will be enrolled All participants will be followed for 6 months after the initiation of oncology drug therapy Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation All patients will be randomly divided into test and control groups Patients in the test group will receive oral Bifidobacterium trivium capsules for 6 months in addition to conventional treatment whereas patients in the control group will receive conventional antitumor treatment only
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