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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06295575
Other study ID # ZZhang
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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