A Multi-center, Randomized, Controlled Trial: Live Combined Bifidobacterium and Lactobacillus Triplex Viable Tablets in Antibiotic-associdated Diarrhea in Children

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044914

Enrollment

Unknown

Registered

2021-03-31

Start date

2021-04-01

Completion date

Unknown

Last updated

2021-11-02

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

Conditions

Antibiotic-associdated Diarrhea

Interventions

Experimental group:To take live combined Bifidobacterium and Lactobacillus tablets orally

Control group:None

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.Children diagnosed by doctors with acute lower respiratory tract infection which needs treatment of antibiotics; 2.Absence of congenital or hereditary diseases; 3.Upon informed consent, the guardian agrees to participate in the program.

Exclusion criteria

Exclusion criteria: 1.Diarrhea before the administration of antibiotics; 2.Patients with diseases of cardiovascular, blood system, liver and kidney; 3.Participation in other pharmaceutical clinical trials in the latest three months; 4.Systemic antibiotic treatment in the latest three months; 5.Immune deficiency; 6.Previous allergic to bifidobacteria, lactobacillus, streptococcus thermophilus components; 7.Course of disease over two weeks in the treatment of respiratory tract infection; 8.The diagnosis was infectious diarrhea.

Design outcomes

Primary

Measure	Time frame
Blood routine examination;Serum infammatory cytokines;Sputum microbiome analysis;Fecal microbiome analysis;	—

Countries

China

Contacts

Public ContactChen Lina

West China Second University Hospital of Sichuan University

chenlina_78@163.com+86 13678003876

Outcome results

None listed

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