<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/NCT03840538</url>
  </required_header>
  <id_info>
    <org_study_id>20112012</org_study_id>
    <nct_id>NCT03840538</nct_id>
  </id_info>
  <brief_title>Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome</brief_title>
  <official_title>Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's&#xD;
      syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized&#xD;
      by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS&#xD;
      patients are most liable to oral candidiasis , so they need prophylaxis aganist oral&#xD;
      candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate&#xD;
      amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral&#xD;
      candidosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>5 WEEKS</time_frame>
    <description>Numerical Rating Scale ( NRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Candidal load</measure>
    <time_frame>5 weeks</time_frame>
    <description>colony forming unit CFU/ml</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Sjogren's Syndrome</condition>
  <arm_group>
    <arm_group_label>Probiotic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Probiotic complex capsule taken twice daily for 5weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule taken twice daily for 5 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotic Product - Cap</intervention_name>
    <description>probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus</description>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_label>Probiotic group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary or scondary Sjogren's syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to milk derivatives previous intake of antifungals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>9112</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Yasmine Kamal Ramadan</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03840538
org study id: 20112012
nct id: NCT03840538
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's
      syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized
      by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS
      patients are most liable to oral candidiasis , so they need prophylaxis aganist oral
      candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate
      amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral
      candidosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Pain assessment
time frame: 5 WEEKS
description: Numerical Rating Scale ( NRS)
measure: Candidal load
time frame: 5 weeks
description: colony forming unit CFU/ml
arm group label: Probiotic group
arm group type: Experimental
description: Probiotic complex capsule taken twice daily for 5weeks
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo capsule taken twice daily for 5 weeks
intervention type: Drug
intervention name: Probiotic Product - Cap
description: probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus
arm group label: Placebo group
arm group label: Probiotic group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Yasmine Kamal Ramadan
investigator title: Assistant lecturer
mesh term: Sjogren's Syndrome
mesh term: Syndrome