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

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 Overview

• Status: Completed
• Conditions: Dysbiosis; Congenital Heart Disease; Intestinal Disease
• Intervention / Treatment: Dietary supplement: probiotics containing Bifidobacterium infantis and Lactobacillus; Dietary supplement: placebos containing lactose

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210093
      • Children's Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group; In treatment group, patients received 1×109 colony forming units (CFU) /day of probiotic, which was provided by Hangzhou Grand Biologic Pharmaceutical INC (Zhejiang, China) in the form of freeze-dried powder containing Bifidobacterium infantis and Lactobacillus with a density of 109 CFU/g. The probiotic powder was mixed with lactose and portioned into sachets with the help of Nanjing Medical University Central Pharmacy.	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.
Placebo Comparator: Control group; Patients in the control group received lactose as placebo. The placebo was packed in sachets and provided in the same way as treatment group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Nanjing Children's Hospital
• Investigators: Principal Investigator: Zhixuan Zhang, Nanjing Children's Hospital; Study Director: Xiaoxu Liu, Department of Cardiothoracic Surgery, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Cardiovascular Abnormalities; Heart Diseases; Intestinal Diseases; Heart Defects, Congenital; Dysbiosis
• Other Study ID Numbers: ZZhang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collation and website construction have not yet been completed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No