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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
Jiangsu Famous Medical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic-associated Diarrhea

Eligibility Criteria

1 Month - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    August 18, 2016
    Last Updated
    December 12, 2016
    Sponsor
    Jiangsu Famous Medical Technology Co., Ltd.
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    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

    Learn more about this trial

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