<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993419</url>
  </required_header>
  <id_info>
    <org_study_id>dbzy160801</org_study_id>
    <nct_id>NCT02993419</nct_id>
  </id_info>
  <brief_title>Bacillus Particles Prevent Children Antibiotics Associated Diarrhea</brief_title>
  <official_title>Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Famous Medical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Famous Medical Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study,&#xD;
      into the group of children in the hospital that use clinical antibiotics from one month to&#xD;
      three years old，by observing the given antibiotics at the same time with the whole bowel raw&#xD;
      or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole&#xD;
      bowel prevention clinical efficacy and safety of AAD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study,&#xD;
      into the group of children in the hospital that use clinical antibiotics from one month to&#xD;
      three years old，by observing the given antibiotics at the same time with the whole bowel raw&#xD;
      or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole&#xD;
      bowel prevention clinical efficacy and safety of AAD.&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
        1. MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily&#xD;
           rates), the duration of diarrhea, the degree of diarrhea occur.&#xD;
&#xD;
        2. Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental&#xD;
           changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Record daily stool frequency, shape observation excrement</measure>
    <time_frame>every day，A total of seven days</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Strain type</measure>
    <time_frame>the first day and the seven day</time_frame>
    <description>Detection of intestinal strains of the species</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Antibiotic-associated Diarrhea</condition>
  <arm_group>
    <arm_group_label>Bacillus licheniformis Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bacillus licheniformis Intervention</intervention_name>
    <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</description>
    <arm_group_label>Bacillus licheniformis Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo Intervention</intervention_name>
    <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</description>
    <arm_group_label>placebo Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children aged 1-3 years&#xD;
&#xD;
          2. no diarrhea-related symptoms&#xD;
&#xD;
          3. the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in&#xD;
             hospitalized children&#xD;
&#xD;
          4. the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days,&#xD;
             combined with other antimicrobial agents alone&#xD;
&#xD;
          5. parent or guardian signed informed consent (6）Not used in children with related&#xD;
             traditional Chinese medicine injection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. diarrhea in the group, or 2 weeks before admission into children with diarrhea&#xD;
&#xD;
          2. children with ICU wards, digestive tract malformations, children with gastrointestinal&#xD;
             surgery, congenital heart disease, artificial heart surgery, children with rheumatic&#xD;
             heart disease, infective endocarditis&#xD;
&#xD;
          3. receiving immunosuppressive agents in children&#xD;
&#xD;
          4. Children who received any probiotic preparation 2 weeks before enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993419
org study id: dbzy160801
nct id: NCT02993419
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Record daily stool frequency, shape observation excrement
time frame: every day，A total of seven days
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
measure: Strain type
time frame: the first day and the seven day
description: Detection of intestinal strains of the species
arm group label: Bacillus licheniformis Intervention
arm group type: Experimental
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 group label: placebo Intervention
arm group type: Placebo Comparator
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: Bacillus licheniformis 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
arm group label: Bacillus licheniformis Intervention
intervention type: Other
intervention name: placebo 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
arm group label: placebo Intervention
criteria: 
gender: All
minimum age: 1 Month
maximum age: 3 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diarrhea
sharing ipd: Undecided