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

Nanjing Children's Hospital

Status: Completed

Conditions: Dysbiosis; Intestinal Disease; Congenital Heart Disease

Treatments: Dietary Supplement: placebos containing lactose; Dietary Supplement: probiotics containing Bifidobacterium infantis and Lactobacillus

Study type: Interventional

Funder types: Other

Identifiers

NCT06295575

ZZhang

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 1 month to 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: probiotics containing Bifidobacterium infantis and Lactobacillus

Control group

Placebo Comparator group

Description:

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:

Dietary Supplement: placebos containing lactose