Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 16, 2023
February 1, 2023
5 months
February 6, 2023
February 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The decline rate of global longitudinal strain
The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE.
6 months
Study Arms (2)
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
EXPERIMENTALBifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
conventional antitumor treatment
ACTIVE COMPARATORPatients in the control group will receive conventional antitumor treatment only.
Interventions
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Patients in the control group will receive conventional antitumor treatment only.
Patients in the control group will receive conventional antitumor treatment only.
Patients in the control group will receive conventional antitumor treatment only.
Patients in the control group will receive conventional antitumor treatment only.
Eligibility Criteria
You may qualify if:
- With malignant tumors
- Will receive antitumor drugs
- Could receive regular follow-up for 6 months
- Written informed consent
You may not qualify if:
- Satisfactory echocardiographic images could not be obtained
- Cardiomyopathy
- Coronary artery disease
- Heart failure
- Arrhythmia requiring intervention
- Moderate or severe valvular disease
- Acute myocarditis
- Refractory hypertension
- Participating in other studies of drug intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Cui, Doctor
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2023
First Posted
February 16, 2023
Study Start
February 15, 2023
Primary Completion
July 1, 2023
Study Completion
December 31, 2023
Last Updated
February 16, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share