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Application and clinical significance of Bifidobacterium animalis in perioperative period of heart valve disease

A single-center, single-blind, randomized, placebo-controlled parallel-controlled trial of the safety and efficacy of Bifidobacterium animalis in 18-70-year-old patients with valvular heart disease in the perioperative period

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057556
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart valve disease

Interventions

Test group:Bifidobacterium animalis
Control group:Placebo

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Preoperative cardiac color Doppler ultrasonography was diagnosed as simple heart valve disease, and the patients were treated with valve replacement or plastic surgery under cardiopulmonary bypass. The diagnosis and surgical indications of valvular heart disease are based on the "Clinical Diagnosis and Treatment Guidelines for Cardiovascular Surgery" (2011 edition) compiled by the Chinese Medical Association; 2. The age is 18-70 years old, male and female are not limited; 3. Not complicated with severe heart, lung, kidney, liver dysfunction and metabolic diseases; 4. Patients and their family members understand the situation of this experiment and agree to participate in all terms of this research, sign the informed consent form approved by the ethics committee, agree to accept the current treatment plan, and be able to cooperate with the experiment.

Exclusion criteria

Exclusion criteria: 1. Patients who cannot take orally or absorb gastrointestinal drugs; 2. Those who participated in other clinical trials on probiotics within 30 days before enrollment; 3. Those who have undergone cardiovascular surgery or patients who need to undergo other cardiac surgery at the same time; 4. Pregnant and lactating women; 5. Those who have a history of allergies to experimental drugs or similar drugs, allergic constitution or are currently suffering from allergic diseases; 6. Patients with severe neurological and psychiatric diseases; 7. Those with autoimmune diseases, immunodeficiency diseases, or a history of organ transplantation; 8. Patients with severe heart, lung, kidney, liver dysfunction and metabolic diseases; 9. Patients who are considered unsuitable for inclusion in this study by the investigator.

Design outcomes

Secondary

MeasureTime frame
White blood cell count;Cardiac Function;Liver function;Kidney function;

Primary

MeasureTime frame
Gastrointestinal symptom score;Stool high-throughput sequencing;

Countries

China

Contacts

Public ContactTang Yanhua

The Second Affiliated Hospital of Nanchang University

tyh6565@163.com+86 13517081828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026