NCT06295575

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

The Effect of Probiotics on Intestinal Barrier Function and Intestinal Flora in Infants With Congenital Heart Disease Undergoing Cardiopulmonary Bypass

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Nanjing Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 1 Year
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2024-03-06
• Last updated: 2024-03-06

Locations

1 site across 1 country: China