NCT02993419

Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Jiangsu Famous Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 1 Month – 3 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Antibiotic-associated Diarrhea

Interventions

Type	Name	Description
DRUG	Bacillus licheniformis Intervention	On the basis of the use of antibiotics in children with symptomatic treatment, the addition of experimental drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation
OTHER	placebo Intervention	On the basis of the use of antibiotics in children with symptomatic treatment, the addition of placebo drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-09-01
• Completion: 2018-02-01
• First posted: 2016-12-15
• Last updated: 2016-12-15