<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/NCT03032003</url>
  </required_header>
  <id_info>
    <org_study_id>Cranberries1</org_study_id>
    <nct_id>NCT03032003</nct_id>
  </id_info>
  <brief_title>Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women</brief_title>
  <official_title>Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women: A Randomized, Comparative, Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Thessaly</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate if oral administration of 240mg PAC of cranberries can reduce the number of&#xD;
      episodes of acute bacterial cystitis and improve general QoL in women with recurrent&#xD;
      bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the&#xD;
      adverse effect profile of the drug will be reported.&#xD;
&#xD;
      Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from&#xD;
      the outpatient population who present to their family physician or specialist with&#xD;
      symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will&#xD;
      be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be&#xD;
      taken from all the patients. Antibiotic treatment will be prescribed (using the drug of&#xD;
      choice according to the urine culture and the treating physician choice). Subsequently, they&#xD;
      will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean&#xD;
      240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment&#xD;
      and after a negative urinary culture patients will continue to receive per os, daily, one&#xD;
      capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.&#xD;
&#xD;
      Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection,&#xD;
      vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12&#xD;
      visits.&#xD;
&#xD;
      Participants will be asked about medication usage, any side effects they may be experiencing&#xD;
      at each study visit. If participants develop a UTI at any time during the study, they will be&#xD;
      asked to visit the study site within 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2018</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women.</measure>
    <time_frame>12 months</time_frame>
    <description>Follow up with urinary cultures will be evaluated for Cranberries affection in UTIs</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Recurrent Urinary Tract Infections in Women</condition>
  <arm_group>
    <arm_group_label>Cysticlean arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cysticlean (2 BID for 15 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (2 BID for 15 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cysticlean</intervention_name>
    <description>2 BID for 15 days</description>
    <arm_group_label>Cysticlean arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 BID for 15 days</description>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Negative urine culture&#xD;
&#xD;
          -  At least 3 UTI's within 12 months prior to study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anatomic abnormalities of the urinary tract&#xD;
&#xD;
          -  Use of investigational drugs within 30 days prior to study entry&#xD;
&#xD;
          -  Current use of warfarin&#xD;
&#xD;
          -  Allergy or intolerance of cranberry products&#xD;
&#xD;
          -  &gt; 50 ml of residual urine (measured by US)&#xD;
&#xD;
          -  Use of indwelling catheter&#xD;
&#xD;
          -  uncontrolled diabetes&#xD;
&#xD;
          -  creatinine &gt; 250 mmol/l,&#xD;
&#xD;
          -  Symptomatic vaginitis&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vasileios Tzortzis, Associated Professor</last_name>
    <email>tzorvas@otenet.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Samarinas, Consultant</last_name>
    <email>mikesamih@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Vasileios Tzortzis</investigator_full_name>
    <investigator_title>Associated Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Recurrence</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/NCT03032003
org study id: Cranberries1
nct id: NCT03032003
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate if oral administration of 240mg PAC of cranberries can reduce the number of
      episodes of acute bacterial cystitis and improve general QoL in women with recurrent
      bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the
      adverse effect profile of the drug will be reported.

      Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from
      the outpatient population who present to their family physician or specialist with
      symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will
      be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be
      taken from all the patients. Antibiotic treatment will be prescribed (using the drug of
      choice according to the urine culture and the treating physician choice). Subsequently, they
      will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean
      240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment
      and after a negative urinary culture patients will continue to receive per os, daily, one
      capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.

      Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection,
      vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12
      visits.

      Participants will be asked about medication usage, any side effects they may be experiencing
      at each study visit. If participants develop a UTI at any time during the study, they will be
      asked to visit the study site within 24 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women.
time frame: 12 months
description: Follow up with urinary cultures will be evaluated for Cranberries affection in UTIs
arm group label: Cysticlean arm
arm group type: Active Comparator
description: Cysticlean (2 BID for 15 days)
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Placebo (2 BID for 15 days)
intervention type: Other
intervention name: Cysticlean
description: 2 BID for 15 days
arm group label: Cysticlean arm
intervention type: Other
intervention name: Placebo
description: 2 BID for 15 days
arm group label: Placebo arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Vasileios Tzortzis, Associated Professor
email: tzorvas@otenet.gr
last name: Michael Samarinas, Consultant
email: mikesamih@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Vasileios Tzortzis
investigator title: Associated Professor
mesh term: Urinary Tract Infections
mesh term: Cystitis
mesh term: Recurrence