Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

Antibiotic-associated Diarrhea Clinical Trial

Official title: Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial

Status Not yet recruiting

Clinical Trial Summary

This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.

Clinical Trial Description

This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.

Outcome measures

1. MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.

2. Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Diarrhea

• NCT number: NCT02993419
• Study type: Interventional
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2016
• Completion date: February 2018