Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

Phase 4

• Conditions: Antibiotic-associated Diarrhea
• Interventions: Drug: Bacillus licheniformis Intervention; Other: placebo Intervention

• Registration Number: NCT02993419
• Lead Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2016-08-18
• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-12
• Last Update Submitted: 2016-12-12
• Study First Posted: 2016-12-15
• Last Update Posted: 2016-12-15
• Primary Completion: 2017-09
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Children aged 1-3 years
2. no diarrhea-related symptoms
3. the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children
4. the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone
5. parent or guardian signed informed consent (6）Not used in children with related traditional Chinese medicine injection

Exclusion Criteria

1. diarrhea in the group, or 2 weeks before admission into children with diarrhea
2. children with ICU wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis
3. receiving immunosuppressive agents in children
4. Children who received any probiotic preparation 2 weeks before enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacillus licheniformis Intervention	Bacillus licheniformis Intervention	The intervention is use Bacillus licheniformis particles，The 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
placebo Intervention	placebo Intervention	The intervention is use placebo，The 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

Primary Outcome Measures

Name	Time	Method
Record daily stool frequency, shape observation excrement	every day，A total of seven days	Record daily stool frequency, excrement shape. According to Bristol who Chart of shape evaluation standard of excrement and urine, feces traits can be divided into seven grades, as picture shown in feces traits scale, record with feces corresponding score, score 5 or more, it indicates that the waste is not normal, diarrhea symptoms

Secondary Outcome Measures

Name	Time	Method
Strain type	the first day and the seven day	Detection of intestinal strains of the species