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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06295575
• Other study ID #: ZZhang
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2024
• Source: Nanjing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Dysbiosis
• Heart Defects, Congenital
• Heart Diseases
• Intestinal Disease
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 1 months
Primary	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	up to 1 months
Primary	biomarkers	serum concentrations of biomarkers of intestinal barrier function and intestinal inflammation, namely IFABP, DAO, D-LA and CRP, were recorded	after anesthesia induction preoperatively and at 24 hour postoperatively
Primary	microbiome	16s rDNA sequencing	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