<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/NCT01679366</url>
  </required_header>
  <id_info>
    <org_study_id>0054-11-ZIV</org_study_id>
    <nct_id>NCT01679366</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients</brief_title>
  <official_title>The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziv Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult&#xD;
      patients may shorten the duration, and reduce the severity of the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may&#xD;
      shorten the duration, and reduce the severity of the disease.&#xD;
&#xD;
      Study design A prospective, randomized, placebo-controlled, double-blinded study comparing&#xD;
      treatment with probiotics to placebo in patients with AP.&#xD;
&#xD;
      The study will be conducted in accordance with the ethical standards of the Helsinki&#xD;
      Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv&#xD;
      Medical Center. Signed informed consent will be required from all patients before inclusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>period of disease</measure>
    <time_frame>10 days</time_frame>
    <description>Patients will be followed daily while hospitalized. After discharge patients will fill a daily dairy for 10 days and record symptoms, signs, drinking, eating, and return to normal life. All dairies will be collected on day 10 of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analysis</measure>
    <time_frame>10 days</time_frame>
    <description>Follow-up throat culture, CBC, CRP, and ESR on day 4 of the study or at discharge if before. For patients with abnormal laboratory tests on admission, repeat tests are performed before discharge according to the routine of the department. For patients with normal tests on admission, these tests will be part of the study. For patients with Streptococcus pyogenes growth on admission and day 4 of the study, another throat culture will be done on day 10 of the study</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Throat Pain</condition>
  <arm_group>
    <arm_group_label>Penicillin G</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>hospitalization of 30 patients given penicilline intraveniously for 72 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 hospitalized patients will be given placebo with a regular penicillin treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Probiotics will be given to 30 hospitalized patients with regular penicillin treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1 tablet 2 times daily</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Sugar pill for mimic probiotics</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <description>1 tablet twice daily</description>
    <arm_group_label>Probiotic</arm_group_label>
    <other_name>BLIS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic&#xD;
             treatment and/or fluids is needed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current therapy with systemic prednisone or equivalent at 20 mg/d for more than 10&#xD;
             days prior to inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonid Livshits, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ziv Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ziv Medical Center</name>
      <address>
        <city>Safed</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2011</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>October 21, 2014</last_update_submitted>
  <last_update_submitted_qc>October 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01679366
org study id: 0054-11-ZIV
nct id: NCT01679366
lead sponsor: 
has dmc: Yes
The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult
      patients may shorten the duration, and reduce the severity of the disease.
Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may
      shorten the duration, and reduce the severity of the disease.

      Study design A prospective, randomized, placebo-controlled, double-blinded study comparing
      treatment with probiotics to placebo in patients with AP.

      The study will be conducted in accordance with the ethical standards of the Helsinki
      Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv
      Medical Center. Signed informed consent will be required from all patients before inclusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: period of disease
time frame: 10 days
description: Patients will be followed daily while hospitalized. After discharge patients will fill a daily dairy for 10 days and record symptoms, signs, drinking, eating, and return to normal life. All dairies will be collected on day 10 of the study.
measure: analysis
time frame: 10 days
description: Follow-up throat culture, CBC, CRP, and ESR on day 4 of the study or at discharge if before. For patients with abnormal laboratory tests on admission, repeat tests are performed before discharge according to the routine of the department. For patients with normal tests on admission, these tests will be part of the study. For patients with Streptococcus pyogenes growth on admission and day 4 of the study, another throat culture will be done on day 10 of the study
arm group label: Penicillin G
arm group type: No Intervention
description: hospitalization of 30 patients given penicilline intraveniously for 72 hours
arm group label: Placebo
arm group type: Placebo Comparator
description: 30 hospitalized patients will be given placebo with a regular penicillin treatment
arm group label: Probiotic
arm group type: Experimental
description: Probiotics will be given to 30 hospitalized patients with regular penicillin treatment
intervention type: Drug
intervention name: Placebo
description: 1 tablet 2 times daily
arm group label: Placebo
other name: Sugar pill for mimic probiotics
intervention type: Drug
intervention name: Probiotics
description: 1 tablet twice daily
arm group label: Probiotic
other name: BLIS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leonid Livshits, MD
role: Principal Investigator
affiliation: Ziv Medical Center
facility: 
country: Israel
responsible party type: Sponsor