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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02993419
• Other study ID #: dbzy160801
• 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

• Antibiotic-associated Diarrhea
• Diarrhea

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