Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210093 | China |
Data collation and website construction have not yet been completed
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D007410 | Intestinal Diseases |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C100843 | Lacteol |
Not provided
Not provided
Not provided