Congenital Heart Disease, Dysbiosis, Intestinal Disease
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTprobiotics 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_SUPPLEMENTplacebos containing lactose
Patients received lactose as placebo.This intervention was started the day after patients' administration and lasted until the day before discharge.
Sponsors
Nanjing Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 1 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of morbidity | up to 1 months | 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 |
| gastrointestinal functional recovery indicators | up to 1 months | starting time of full enteral feeding (hours post-surgery) and duration of gastrointestinal decompression were recorded for assessment of gastrointestinal functional recovery |
| biomarkers | after anesthesia induction preoperatively and at 24 hour postoperatively | serum concentrations of biomarkers of intestinal barrier function and intestinal inflammation, namely IFABP, DAO, D-LA and CRP, were recorded |
| microbiome | 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 | 16s rDNA sequencing |
Countries
China
Outcome results
None listed