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The effect of Biostime lactoferrin probiotics on respiratory infections in infants and preschool children

The effect of Biostime lactoferrin probiotics on respiratory infections in infants and preschool children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111308
Enrollment
Unknown
Registered
2025-10-29
Start date
2025-11-01
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

respiratory infections

Interventions

Control group:Oral placebo

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: (1) Healthy children; (2) Currently either exclusively formula-fed or not consuming formula milk; (3) Aged 0–6 years (divided into two groups: 0–3 years and 4–6 years); (4) Have experienced at least one episode of upper respiratory tract infection within the past year

Exclusion criteria

Exclusion criteria: (1) Currently breastfed or mixed-fed infants; (2) Exclusively formula-fed infants consuming formula with high lactoferrin or high *Bifidobacterium bifidum* (BB12) content; (3) Children who have been continuously consuming probiotic or lactoferrin-related products; (4) Children with severe infections or a history of surgical procedures; (5) Personal or family history of milk allergy or lactose intolerance.

Design outcomes

Primary

MeasureTime frame
The number of episodes with upper respiratory tract infection–related symptoms, such as cough, fever, or nasal discharge.;

Secondary

MeasureTime frame
Changes in salivary immune factors (IL-1ß, IL-6, TNF-a, and CRP).;Clinical symptoms: severity and duration of the common cold, and occurrence of symptoms such as cough, fever, and nasal discharge.;Gut health: incidence and severity of gastrointestinal discomfort symptoms, and changes in gut microbiota composition.;

Countries

China

Contacts

Public ContactZhang Jiahui

Shanghai Sixth People's Hospital

jialinzhang_2007@126.com+86 180 1757 9665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 12, 2026