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Application and clinical significance of lactobacillus plantarum in the perioperative period of congenital heart disease

A randomized, single-blind, placebo-controlled parallel trial evaluating the safety and efficacy of lactobacillus plantarum in the perioperative population of congenital heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058043
Enrollment
Unknown
Registered
2022-03-27
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

congenital heart disease

Interventions

Experimental group:Lactobacillus plantarum

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with simple congenital heart disease by preoperative color Doppler ultrasound and treated with interventional occlusion or extracorporeal circulation surgery. The diagnosis and surgical indications of congenital heart disease are based on the Clinical Guidelines for Cardiovascular Surgery (2011 edition) compiled by the Chinese Medical Association; 2. Aged between 3-70 years, no gender limit; 3. No serious heart, lung, kidney, liver dysfunction or metabolic diseases; 4. The patient and the patient's family understand the situation of this experiment and agree to participate in all terms of this study, sign the informed consent approved by the Ethics Committee, agree to accept the current treatment plan, and can cooperate with the experiment.

Exclusion criteria

Exclusion criteria: 1. Patients who cannot take oral or absorb digestive tract drugs; 2. Participate in other clinical trials on probiotics within 30 days before enrollment; 3. Patients who have received cardiovascular surgery before surgery or who need to receive other types of great vascular surgery during the same period; 4. Pregnant and lactating patients; 5. Patients with severe neurological or psychiatric diseases; 6. Patients with autoimmune diseases, immune deficiency diseases, or a history of organ transplantation; 7. Those who were considered unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
gastrointestinal symptom score;

Secondary

MeasureTime frame
white blood cell count;renal function;cardiac function;

Countries

China

Contacts

Public ContactTang Yanhua
tyh6565@163.com+86 13517081828

Outcome results

None listed

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