Pediatric Antibiotic-Associated Diarrhea
Conditions
Interventions
Experimental Group:Experimental Group: Conventional therapy (including antibiotics) plus Saccharomyces boulardii sachets, for a treatment duration of 5 to 14 days.
Saccharomyces boulardii sachets shal
Control Group:Control Group: Conventional therapy (including antibiotics) for a treatment duration of 5 to 14 days.
For children who develop diarrhea during the study period, treatment shall be admini
Sponsors
Shenzhen Children's Hospital
Eligibility
Sex/Gender
All
Age
0.5 Years to 3 Years
Inclusion criteria
Inclusion criteria: 1.Children aged 6 months to 3 years inclusive, of either sex; 2.Pediatric patients with lower respiratory tract infections (including tracheobronchitis, bronchiolitis, and pneumonia) who are scheduled to receive oral or intravenous antibiotic therapy for 5 to 14 days; 3.Legal guardians have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with hypersensitivity to Saccharomyces boulardii sachets or existing contraindications to the study intervention; 2.A history of diarrhea within 2 weeks prior to enrollment; 3.Subjects with any of the following laboratory test results at screening: (1). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2 × upper limit of normal (ULN) (2). ?-glutamyl transferase (GGT) >= 2 × ULN (3). Serum creatinine (SCr) >= ULN (4). Hemoglobin 5 cells/high-power field (HPF) on routine stool examination at screening; 5.Presence of severe or life-threatening diseases, including current admission to the intensive care unit (ICU), complicated with malignant tumors, congenital heart disease with hemodynamic changes, and a history of previous artificial heart valve surgery, etc.; 6.Gastrointestinal diseases: a history of previous gastrointestinal malformations, Hirschsprung's disease, short bowel syndrome, inflammatory bowel disease, or gastrointestinal surgery within 6 months prior to enrollment; or current complications such as gastrointestinal bleeding, gastroesophageal reflux disease (GERD), or dysphagia; 7.Other severe underlying diseases or chronic diseases that may affect the intestinal flora: such as a history of previous chromosomal abnormalities, monogenic genetic diseases (cystic fibrosis, congenital disorders of glycosylation, congenital diarrhea), etc.; current complications such as malnutrition (weight-for-length/height < -2 standard deviations [SD]), or current systemic bloodstream infections such as sepsis and bacteremia; 8.Currently receiving or expected to receive tube feeding during the study period; 9.A history of immunodeficiency diseases or need for systemic immunosuppressive therapy during the study period [glucocorticoids at a prednisone-equivalent dose < 10 mg/kg/day are permitted]; 10.Use of proton pump inhibitors (PPIs), laxatives, or antidiarrheal agents within 2 weeks prior to enrollment; 11.Receipt of any probiotic preparations within 4 weeks prior to enrollment; 12.Use of antibiotics within 4 weeks prior to enrollment; 13.For breastfed or mixed-fed infants, the mother has used antibiotics within 2 weeks prior to the infant’s enrollment; 14.Oxygen saturation = 92% without oxygen therapy; 15.Use of traditional Chinese medicine (including Chinese herbal medicines, decoctions, and proprietary Chinese medicines) within 1 week prior to enrollment; 16.Any other circumstances that the investigator deems unsuitable for the subject to participate in the study, which may affect the evaluation of the efficacy and/or safety of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Pediatric Antibiotic-Associated Diarrhea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of All-Cause Diarrhea;Average Daily Number of Bowel Movements;Stool Consistency;Duration of Diarrhea;Severity of Diarrhea;Time to Resolution of Associated Symptom (Vomiting); | — |
Countries
China
Contacts
Public ContactZheng Yuejie
Shenzhen Children's Hospital
Outcome results
None listed