Bacillus Particles Prevent Children Antibiotics Associated Diarrhea
Primary Purpose
Antibiotic-associated Diarrhea
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bacillus licheniformis Intervention
placebo Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Antibiotic-associated Diarrhea
Eligibility Criteria
Inclusion Criteria:
- Children aged 1-3 years
- no diarrhea-related symptoms
- the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children
- the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone
- parent or guardian signed informed consent (6)Not used in children with related traditional Chinese medicine injection
Exclusion Criteria:
- diarrhea in the group, or 2 weeks before admission into children with diarrhea
- children with ICU wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis
- receiving immunosuppressive agents in children
- Children who received any probiotic preparation 2 weeks before enrollment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bacillus licheniformis Intervention
placebo Intervention
Arm Description
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
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
Outcomes
Primary Outcome Measures
Record daily stool frequency, shape observation excrement
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
Strain type
Detection of intestinal strains of the species
Full Information
NCT ID
NCT02993419
First Posted
August 18, 2016
Last Updated
December 12, 2016
Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02993419
Brief Title
Bacillus Particles Prevent Children Antibiotics Associated Diarrhea
Official Title
Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.
Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bacillus licheniformis Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
placebo Intervention
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bacillus licheniformis Intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
placebo Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Record daily stool frequency, shape observation excrement
Description
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
Time Frame
every day,A total of seven days
Secondary Outcome Measure Information:
Title
Strain type
Description
Detection of intestinal strains of the species
Time Frame
the first day and the seven day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 1-3 years
no diarrhea-related symptoms
the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children
the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone
parent or guardian signed informed consent (6)Not used in children with related traditional Chinese medicine injection
Exclusion Criteria:
diarrhea in the group, or 2 weeks before admission into children with diarrhea
children with ICU wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis
receiving immunosuppressive agents in children
Children who received any probiotic preparation 2 weeks before enrollment
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Bacillus Particles Prevent Children Antibiotics Associated Diarrhea
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