Idiopathic short stature
Conditions
Interventions
Probiotic group:rhGH basic treatment + Lactobacillus Josii combined with Lactococcus lactis subspecies complex probiotics for auxiliary intervention.
Placebo group:rhGH basic treatment + placebo (maltodextrin) as an auxiliary intervention.
Sponsors
Jingdezhen Second People’s Hospital
Eligibility
Sex/Gender
All
Age
4 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Age 4-10 years, both genders, Tanner stage I (prepubertal, i.e., no breast development, testicular volume =10 ng/mL in two different pharmacological stimulation tests (according to the 2023 Chinese Expert Consensus on the Diagnosis and Treatment of Idiopathic Short Stature in Children). Note: The current international consensus recommends a cutoff of 7 ng/mL, and 56.76% of experts in the Chinese consensus group also support 7 µg/L; however, the current national standard still uses 10 µg/L. This study uses 10 µg/L to ensure diagnostic standardization and comparability with domestic studies. Children with GH peak values between 7-10 ng/mL will be included in a pre-specified subgroup analysis. 4. Normal birth length and weight (appropriate for gestational age, excluding small for gestational age [SGA]). 5. Annual growth velocity (HV) =8 years, a child-friendly assent form also signed.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any component of the study drug (including rhGH, probiotic strains, and excipients). 2. Prior treatment with rhGH, gonadotropin-releasing hormone analogues (GnRHa), aromatase inhibitors, or glucocorticoids. 3. Presence of organic gastrointestinal diseases, including inflammatory bowel disease, celiac disease, *Helicobacter pylori* infection (positive ¹³C urea breath test), chronic diarrhea, malabsorption syndrome, etc. 4. Chromosomal abnormalities or genetic syndromes, such as Turner syndrome, Noonan syndrome, Silver-Russell syndrome, Prader-Willi syndrome, SHOX gene defects, etc. 5. Severe chronic systemic diseases, including congenital heart disease, chronic liver/kidney disease, uncontrolled asthma, diabetes mellitus, or uncorrected thyroid dysfunction. 6. Severe malnutrition (BMI SDS +2). 7. Use of probiotics, prebiotics, synbiotics, or antibiotics within 1 month before screening. 8. Participation in other interventional clinical trials within 3 months before screening. 9. Presence of sleep-disordered breathing (e.g., obstructive sleep apnea), narcolepsy, or cross-time-zone travel within the past 3 months. 10. Severe neurological or psychiatric disorders (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder, etc.) that may affect study compliance. 11. Other conditions deemed by the investigator to make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth rate of the year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of IGF-1, IGFBP-3 and IGF-1/IGFBP-3;Gut microbiota;Changes in height SDS;Changes in body weight SDS and BMI SDS;Bone age change ratio;Sleep quality score;Symptom relief rate of functional gastrointestinal disorders;Safety indicators: Incidence of adverse events (AE) and serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactLei Xuewei
Jingdezhen Second People’s Hospital
Outcome results
None listed