ISS
Conditions
Interventions
control group:Placebo
test group:Bifidobacterium animalis subsp. lactis BL-11
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
3 Years to 9 Years
Inclusion criteria
Inclusion criteria: 1. Pre-pubertal patients (Tanner stage I, boys 3 years old = 10.0ng/ml confirmed by two different drugs GH stimulation test; 5) Bone age (BA)-chronological age (CA) = 24 weeks; and 3) height at screening below the 3rd percentile of height for children of the same age and sex. 3).Turner syndrome: 1) Karyotype: 45,X,45,X/46,XXqi,45,X/46,XXr,45,X/46,XX,46,XXqi,46,XXpi,45,X/47,XXX,46,XXp-,45,X/46,XXp-,46,XXq-, 45X/46,XXq-, 45X/46, 45Xq-, 45X/46,XXq-, etc; 2) Having at least one specific somatic feature: including low posterior hairline, facial skin pigmentation nevus, neck webbing, short neck, ear position, etc; 2) Having at least one specific somatic feature: including low posterior hairline, facial skin pigmentation nevus, neck webbing, short neck, short neck, short neck, ear position, etc. X/46,XX/47,XXX, etc.; 2) have at least one specific physical characteristic including, but not limited to, low posterior hairline, facial skin pigmented nevus, webbed neck, short neck, low-set ears, small jaw, high palatal arches, peltate, wide breast spacing, valgus, valgus, valgus, short 4th and 5th metacarpals, nail dysplasia, scoliosis, ptosis, squint, and cardiovascular system abnormalities such as aortic stenosis, bileaflet aortic valve, hypertension, reproductive system anomalies such as primary glandular insufficiency, renal malformations, hypothyroidism, and middle ear pathology, etc.; 3) Height below the 3rd percentile of normal height for children of the same age and sex at the time of screening.
Exclusion criteria
Exclusion criteria: 1. Small for gestational age: children with diagnosed or suspected Bloom syndrome; 2. Turner syndrome: the presence of Y chromosomes or segments derived from Y chromosomes; 3. Those whose epiphyses have closed; 4. Patients with diagnosed or highly suspected growth hormone deficiency (GHD) and other types of growth abnormalities: e.g., Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome; 5. Those who have received systemic (more than 1 month) growth-promoting therapies, including but not limited to rhGH, aromatase inhibitors, and sex hormones; 6. Are receiving or require long-term administration of other treatments that may have an effect on growth, including but not limited to glucocorticoids, methylphenidate; 7. Those with abnormal values of liver and kidney function (ALT > 1.5 ULN, Cr > 1 ULN); 8. Suffer from chronic infectious diseases: such as chronic hepatitis B, AIDS or tuberculosis; 9. Severe allergies or hypersensitivity to growth hormone or its excipients such as mannitol, lysine, and sodium chloride; 10. Persons with a history of prior malignancy or current active malignancy, including intracranial tumors; 11. Individuals with abnormal glucose regulation (including abnormal fasting glucose and/or abnormal glucose tolerance) or diabetes mellitus; 12. Persons with mental illness or a family history of mental illness; 13. Suffer from chronic systemic diseases such as malnutrition, immunocompromised individuals, asthma, etc; 14. Those with congenital intracranial hypertension; 15. Those with slipped capital femoral epiphysis (SCFE); 16. Scoliosis greater than 15°; 17. those who have participated (as a subject) in a clinical trial of any drug within 3 months prior to screening and have received a pharmacologic intervention; 18. Those who, in the opinion of the investigator, have other factors that make participation in this trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ht SDS; | — |
Secondary
| Measure | Time frame |
|---|---|
| bone metabolism;hypoglycemia;blood routine examination;blood biochemistry;IGFBP-3;HV;BA/CA;IGF-1;weight;oral bacterial flora;intestinal flora; | — |
Countries
China
Contacts
Public ContactXiaoping Luo
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed