Sleep disorders
Conditions
Interventions
Probiotic group:Receiving intervention with the Bifidobacterium longum subsp. longum strain Dipro-017 preparation
Placebo group:Receiving placebo intervention
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 3–6 years with a balanced sex distribution; gestational age 37–42 weeks and birth weight 2500–4000 g. 2. A total score of >=41 on the Children’s Sleep Habits Questionnaire (CSHQ) at screening. 3. Willingness to refrain from using any medications or foods that may affect sleep during the study period (e.g., foods containing caffeine or xanthines). 4. Parents or other legal guardians fully understand the study and voluntarily sign the informed consent form before any study procedures are initiated.
Exclusion criteria
Exclusion criteria: 1. Presence of behavioral and developmental disorders, psychiatric disorders, or cognitive impairment. 2. Presence of psychiatric or neurodevelopmental conditions such as anxiety disorders, depressive disorders, intellectual disability, or autism spectrum disorder. 3. Children with brain injury, coma, consciousness disorders, epilepsy, or obstructive sleep apnea–hypopnea syndrome. 4. Use of psychiatric medications (e.g., stimulants, anticonvulsants, antihistamines). 5. Presence of allergic rhinitis, food allergies, or other conditions that may affect sleep quality. 6. Presence of respiratory diseases, acute or chronic diarrhea, or severe cardiovascular, cerebrovascular, hepatic, renal, hematologic, or other systemic diseases. 7. Receipt of any vaccination within the past 4 weeks or planned vaccination during the study period. 8. Use of antibiotics, dietary supplements (e.g., magnesium), other probiotics, or other medications or supplements that may affect sleep within 4 weeks before enrollment. 9. Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 3 months. 10. Presence of severe infections or major trauma, or history of medium-to-major surgery within the past month. 11. Known allergy to components of probiotic products. 12. Subjects with potential medical, psychiatric, psychological, or other inappropriate conditions, poor compliance, or deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Habits Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota;Gut metabolites;Gut immune markers;Quality of Life Questionnaire Score; | — |
Countries
China
Contacts
Public ContactYanjun Zhao
Shanghai Children's Hospital
Outcome results
None listed