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

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Intestinal Disease; Dysbiosis
• Interventions: Dietary Supplement: placebos containing lactose; Dietary Supplement: probiotics containing Bifidobacterium infantis and Lactobacillus

• Registration Number: NCT06295575
• Lead Sponsor: Nanjing Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	placebos containing lactose	Patients in the control group received lactose as placebo. The placebo was packed in sachets and provided in the same way as treatment group.
Treatment group	probiotics containing Bifidobacterium infantis and Lactobacillus	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.

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Children's Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China