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

NCT06295575 | Completed

• 1 other identifier: ZZhang
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Intestinal Disease; Dysbiosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Interventions

probiotics containing Bifidobacterium infantis and Lactobacillus DIETARY_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.

Treatment group

placebos containing lactose DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210093, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Intestinal Diseases; Dysbiosis

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhixuan Zhang

  Nanjing Children's Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoxu Liu

  Department of Cardiothoracic Surgery, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 6, 2024
• Study Start: June 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)