Healthy children aged 6–12 years
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: no restriction; aged 6–12 years old at the time of signing the informed consent form; 2. No history of systemic diseases, nutritional disorders, or other conditions that may affect height growth, sleep quality, gastrointestinal function, or calcium metabolism. 3. The subjects and/or their parents/guardians agree to participate in this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. A history of major diseases (including heart, liver, kidney, nervous system, systemic infection, and mental disorders, etc.); 2. Use of drugs affecting growth or gastrointestinal function (e.g., growth hormone, sex hormones, thyroid hormones, laxatives/antidiarrheals, proton pump inhibitors, etc.) within the past month; 3. Known history of severe atopy, or hypersensitivity or intolerance to the study products or their excipients; 4. Participation in other drug clinical trials within 3 months prior to signing the informed consent form; 5. Poor expected medication compliance, or inability of parents/guardians to cooperate with the fulfillment of study requirements; 6. Any other circumstances that, in the investigator’s judgment, make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height; | — |
Secondary
| Measure | Time frame |
|---|---|
| Children's Sleep Habits Questionnaire (CSHQ) Score;Appetite Visual Analog Scale (VAS);Change in height;Metagenomic Sequencing of Intestinal Flora;Gastrointestinal Symptom Rating Scale (GSRS); | — |
Countries
China
Contacts
The Sixth Affiliated Hospital,Sun Yat-sen University