Skip to content

The interventional Study on the Effects of Bifidobacterium longum subsp. infantis SINE006 Combined with Natural Fruit Calcium and Calcium Citrate on the Growth and Development of Children with Idiopathic Short Stature

The interventional Study on the Effects of Bifidobacterium longum subsp. infantis SINE006 Combined with Natural Fruit Calcium and Calcium Citrate on the Growth and Development of Children with Idiopathic Short Stature

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111249
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Short Stature

Interventions

A group:Calcium carbonate
B group:Organic Calcium (Calcium Citrate + Fruit Calcium)
C group:Bifidobacterium longum subsp. infantis SINE006 + Organic Calcium (Calcium Citrate + Fruit Calcium)

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1.Aged 3-8 years, regardless of sex; meeting the diagnostic criteria for idiopathic short stature (ISS); 2.No prior use of growth hormone (GH), or GH treatment duration less than 6 months; 3.No use of probiotics, antibiotics, acid suppressants, or other medications that may affect gut microbiota within the past 1 month. No use of anti-allergic, neuropsychiatric, or immunomodulatory drugs (e.g., glucocorticoids) during the same period; 4.No history of fecal microbiota transplantation (FMT), nutrient injections, or immunoglobulin therapy; 5.No major chronic or severe systemic diseases; 6.Legal guardians must provide signed informed consent and agree to:Participate in the full clinical trial process.Allow collection of blood, and stool samples for research purposes.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.Congenital metabolic diseases or chromosomal abnormalities; 2.Growth hormone (GH) therapy for more than 6 months; 3.Presence of severe underlying diseases or significant liver/kidney dysfunction; 4.Use of probiotics, antibiotics, acid suppressants, or other drugs affecting gut microbiota within the past 1 month; 5.Severe allergic predisposition or current use of anti-allergic medications.

Design outcomes

Primary

MeasureTime frame
Inter-group height SDS difference;

Secondary

MeasureTime frame
Bone age, bone density;Growth hormone levels;Growth factors IGF-1 and IGF-BP-3;Bone-specific alkaline phosphatase;

Countries

China

Contacts

Public ContactGuang Yang

Chinese PLA General Hospital

yang301@sina.com+86 139 8561 6067

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026