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Efficacy and Safety of probiotics for the prevention of child antibiotic-associated diarrhea

Effective of probiotics for preventing child antibiotic-associated diarrhea: a multicenter double-blind randomized placebo-controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TCS-11004978
Enrollment
Unknown
Registered
2011-11-30
Start date
2011-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Antibiotic associated diarrhea

Interventions

Control:Antibiotic therapy plus blank control
Study group:Antibiotic therapy plus probiotic (per sachet containing 5*107 cfu of Clostridium butyricum and 5*108 cfu of Bifidobacterium infantis), taking orally twice daily for consecutive 7 days at

Sponsors

Shenzhen City Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. aged 3 month to 3 years old; 2. with the diagnosis of pneumonia or bronchiolitis and receiving hospitalized therapy; 3. treated with anti-infectious for more than 2 days, regardless of class of anti-infection drug, administration delivery route, simple or combination therapy.

Exclusion criteria

Exclusion criteria: 1. comorbid diarrhea or diarrhea within 15 days before entrance; 2. need to be treated in ICU; 3. treated with long-term immunosuppressive agents; 4. need to be treated with alimentary tract operation; 5. comorbidity with rheumatic heart diseases or infective endocarditis; 6. with the diagnosis of malnutrtion; 7. have been treated with any probiotics preparation or supplementary food including probiotics in 15 days before enrollment.

Design outcomes

Primary

MeasureTime frame
Frequency of any diarrhea and AA;

Secondary

MeasureTime frame
Severity and duration of diarrhe;

Countries

China

Contacts

Public ContactYuejie ZHENG
yuejiez@sina.com+86 13510332369

Outcome results

None listed

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