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A multicenter, randomized, double blind, controlled clinical study ofBacillus Viable particles prevention of child antibiotic-associated diarrhea (ADD)

A multicenter, randomized, double blind, controlled clinical study ofBacillus Viable particles prevention of child antibiotic-associated diarrhea (ADD)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009033
Enrollment
Unknown
Registered
2016-08-16
Start date
2016-10-01
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

Children antibiotic-associated diarrhea(ADD)

Interventions

Test group:Antibiotics and Bacillus Viable particles
control group:Antibiotic and Placebo blank

Sponsors

Shenzhen Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.1 Years to 3 Years

Inclusion criteria

Inclusion criteria: (1) January to 3 year old children; (2) no diarrhea symptoms; (3) diagnosis of respiratory tract infections (acute bronchitis, pneumonia) of Hospitalized children; (4) requires penicillins, cephalosporins antibiotic therapy, treatment course of 7 to 14 days, alone in combination with other antimicrobial agents; (5) a parent or guardian to sign an informed consent form; (6) not used in children related to traditional Chinese medicine injection preparation.

Exclusion criteria

Exclusion criteria: (1) Diarrhea occurs when the group, or the group 2 before happened last week with diarrhea; (2) ICU ward children, gastrointestinal malformations, gastrointestinal surgery in children with congenital heart disease, valvular artificial heart surgery in children with rheumatoid heart disease, infective endocarditis; (3) Treated by immunized inhibitors children; (4) Children received any probiotic preparations in past two weeks.

Design outcomes

Primary

MeasureTime frame
The incidence of diarrhea (Daily stool frequency and character ratings);Time of occurrence of diarrhea;The degree of diarrhea;

Secondary

MeasureTime frame
Intestinal flora and related metabolites;Microenvironment;

Countries

China

Contacts

Public ContactYuejie Zhen

Shenzhen Children's Hospital

yuejiez@sina.com+86 18938690506

Outcome results

None listed

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