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Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

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ClinicalTrials.gov Identifier: NCT02993419
Recruitment Status : Unknown
Verified December 2016 by Jiangsu Famous Medical Technology Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Antibiotic-associated Diarrhea Drug: Bacillus licheniformis Intervention Other: placebo Intervention Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial
Study Start Date : December 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
Experimental: 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
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

Placebo Comparator: 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
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




Primary Outcome Measures :
  1. Record daily stool frequency, shape observation excrement [ Time Frame: 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 :
  1. Strain type [ Time Frame: the first day and the seven day ]
    Detection of intestinal strains of the species



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Jiangsu Famous Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02993419    
Other Study ID Numbers: dbzy160801
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents