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Efficacy of Saccharomyces boulardii CNCM-I 457 in preventing antibiotic-associated diarrhea in infants – a multi-center randomized controlled clinical trial

Efficacy of Saccharomyces boulardii CNCM-I 457 in preventing antibiotic-associated diarrhea in infants – a multi-center randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007369
Enrollment
Unknown
Registered
2012-11-06
Start date
2012-10-01
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 (AAD)

Interventions

intervention group:Children in the intervention group received Saccharomyces boulardii CNCM-I 457, 250 mg once a day, simultaneously with oral antibiotics and symptomatic supportive treatment., Treatm
control group:Patients in the control group received only antibiotics and symptomatic supportive treatment.

Sponsors

West China Second Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: Male or female hospitalized children (aged from 1 month to 3 years old) with non-gastrointestinal infections requiring antibiotic treatment (such as respiratory, urinary tract and otitis media infections) were enrolled. Patients were to be without symptoms of diarrhea during treatment of primary disease with normal stool at time of admission to hospital and <=3 days of antibiotic use prior to hospital admission.

Exclusion criteria

Exclusion criteria: Children with any following conditions were excluded: diarrhea prior to admission, severe immunodeficiency; infusion via central venous catheter (CVC); use of antifungal agents during inpatient treatment and previously known allergy to Saccharomyces boulardii.

Design outcomes

Primary

MeasureTime frame
the presence of diarrhea;the frequency of diarrhea;

Secondary

MeasureTime frame
adverse reactions/events;

Countries

China

Contacts

Public ContactWan Chaomin
wcm0220@126.com+86 13980915296

Outcome results

None listed

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