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

Nanjing Children's Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congenital Heart Disease Intestinal Disease Dysbiosis

Interventions

probiotics containing Bifidobacterium infantis and LactobacillusDIETARY_SUPPLEMENT

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.

placebos containing lactoseDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: * a diagnosis of CHD requiring surgical repair with the use of CPB * age greater than 37 weeks corrected gestational age and less than 1 year old Exclusion Criteria: * Patients with inherited metabolic disease, history of intestinal surgery, preexisting gastrointestinal pathology (such as NEC, IBS, inflammatory bowel disease, chronic intestinal obstruction or diarrhea), immunity dysfunction or received antibiotics, probiotics or hormone-replacement therapy within 2 months before enrollment were excluded from the study

Outcomes

Primary Outcomes

incidence of morbidity

morbidity of intestinal diseases including pathology verified by imageological examination such as necrotizing enterocolitis (NEC) and acute intestinal obstruction or bowel dysfunction such as diarrhea

Time frame: up to 1 months

gastrointestinal functional recovery indicators

starting time of full enteral feeding (hours post-surgery) and duration of gastrointestinal decompression were recorded for assessment of gastrointestinal functional recovery

Time frame: up to 1 months

biomarkers

serum concentrations of biomarkers of intestinal barrier function and intestinal inflammation, namely IFABP, DAO, D-LA and CRP, were recorded

Time frame: after anesthesia induction preoperatively and at 24 hour postoperatively

microbiome

16s rDNA sequencing

Time frame: before surgery: within 24 hours after enrollment in the control group and within 24 hours preoperatively in the treatment group after surgery:between 48 and 72 hours in both groups