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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02993419
Other study ID # dbzy160801
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 18, 2016
Last updated December 12, 2016
Start date December 2016
Est. completion date February 2018

Study information

Verified date December 2016
Source Jiangsu Famous Medical Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 480
Est. completion date February 2018
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 3 Years
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Famous Medical Technology Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 every day,A total of seven days No
Secondary Strain type Detection of intestinal strains of the species the first day and the seven day No
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