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Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass

NCT06295575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease
  • Intestinal Disease
  • Dysbiosis

Interventions

DIETARY_SUPPLEMENT

probiotics containing Bifidobacterium infantis and Lactobacillus

Patients were provided with probiotics containing Bifidobacterium infantis and Lactobacillus. This intervention was started the day after patients' administration and lasted until the day before discharge.

DIETARY_SUPPLEMENT

placebos containing lactose

Patients received lactose as placebo.This intervention was started the day after patients' administration and lasted until the day before discharge.

Sponsors & Collaborators

  • Nanjing Children's Hospital

    lead OTHER

Principal Investigators

  • Zhixuan Zhang · Nanjing Children's Hospital

  • Xiaoxu Liu · Department of Cardiothoracic Surgery, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06295575 on ClinicalTrials.gov