<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/NCT03042273</url>
  </required_header>
  <id_info>
    <org_study_id>PAC-001</org_study_id>
    <nct_id>NCT03042273</nct_id>
  </id_info>
  <brief_title>High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection</brief_title>
  <official_title>A Randomised, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of High Strength Cranberry (Pacran®) in Women With Recurrent Urinary Tract Infections (Cystitis)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swisse Wellness Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Commonwealth Scientific and Industrial Research Organisation, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swisse Wellness Pty Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm&#xD;
      study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in&#xD;
      preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of UTI</measure>
    <time_frame>6 months</time_frame>
    <description>cultured confirmed UTIs at a level of &gt;108cfu/L (105cfu/mL)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>High Strength Cranberry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 capsule of Matching Placebo orally daily for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High Strength Cranberry</intervention_name>
    <description>Softgel capsule</description>
    <arm_group_label>High Strength Cranberry</arm_group_label>
    <other_name>25,000mg Vaccinium macrocarpon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Soy oil to match High Strength Cranberry Softgel Capsule</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo (for High Strength Cranberry)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females aged 18-65 years, inclusive&#xD;
&#xD;
          2. A history of recurrent urinary tract infection defined as ≥3 UTIs in the last year OR&#xD;
             at least 2 UTIs occurring in the last 6 months. Each infection requires confirmation&#xD;
             by a health professional&#xD;
&#xD;
          3. Willing to answer questionnaires and comply with the study requirements&#xD;
&#xD;
          4. Ability to swallow capsules&#xD;
&#xD;
          5. Provided Written Informed Consent&#xD;
&#xD;
          6. BMI &gt;17.5kg m2 and &lt;35kg m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Microbial growth on urine culture of ≥107 cfu/L (104cfu/mL) within 7 days of Day 1&#xD;
&#xD;
          2. A history of &gt;5 UTIs in the last 6 months (confirmed by self-report or health&#xD;
             professional)&#xD;
&#xD;
          3. Use of antibiotics or antibiotics for prophylaxis within 28 days of Day 1&#xD;
&#xD;
          4. Use of any antibacterial products, that in the opinion of the Medical Investigator may&#xD;
             interfere with the study outcomes, within 28 days of Day 1&#xD;
&#xD;
          5. Regular use of Vaccinium containing products (e.g. all forms of blueberries,&#xD;
             cranberries, bilberry, lingonberry , etc i.e fruit, dried fruit, pills, juices or&#xD;
             supplements) within 28 days of Day 1 at the discretion of the Medical Investigator&#xD;
&#xD;
          6. Presence of an intermittent or indwelling urinary catheter&#xD;
&#xD;
          7. Anatomical abnormalities of the urinary tract&#xD;
&#xD;
          8. History of or known clinically significant renal or urological disease(self-reported)&#xD;
&#xD;
          9. Positive urine dipstick pregnancy test at screening onDay 1, currently pregnant and/or&#xD;
             breastfeeding&#xD;
&#xD;
         10. Women of Childbearing potential not willing to use adequate and effective methods of&#xD;
             contraception throughout the study&#xD;
&#xD;
         11. Women of child bearing potential that have not been using effective methods of&#xD;
             contraception for 14 days prior to Day 1&#xD;
&#xD;
         12. History of or known clinically significant cardiac disease&#xD;
&#xD;
         13. History of or known clinically significant liver disease&#xD;
&#xD;
         14. History of or known clinically significant gastrointestinal disease&#xD;
&#xD;
         15. History of or known metabolic disorder or diabetes&#xD;
&#xD;
         16. History or presence of alcohol or illicit drug abuse,any surgical history, clinical&#xD;
             condition or organ dysfunction that in the opinion of the Medical Investigator may&#xD;
             affect the participant's ability to participate in the study or the study results&#xD;
&#xD;
         17. Currently hospitalised or any planned hospitalisations within 1 month following the&#xD;
             last dose of study product&#xD;
&#xD;
         18. Immunocompromised participants or participants receiving immunosuppressive medication&#xD;
&#xD;
         19. History of an adverse reaction or known hypersensitivity or suspected allergy to the&#xD;
             investigational product ingredients&#xD;
&#xD;
         20. Currently taking warfarin or has received Warfarin within 28 days of Day 1&#xD;
&#xD;
         21. Received an investigational drug within 28 days of Day 1&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females with a history of recurrent UTIs</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Welma Stonehouse, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Commonwealth Scientific and Industrial Research Organisation, Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Holdsworth House Medical Centre</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holdsworth House Medical Centre</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Griffith University Clinical Trial Unit (Griffith Health)</name>
      <address>
        <city>Gold Coast</city>
        <state>Queensland</state>
        <zip>4222</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSIRO Nutrition and Health Research Clinic</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Alfred Psychiatry Research Centre (MAPrc)</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>recurrent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03042273
org study id: PAC-001
nct id: NCT03042273
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm
      study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in
      preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Incidence of UTI
time frame: 6 months
description: cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL)
arm group label: High Strength Cranberry
arm group type: Experimental
description: 1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months
arm group label: Placebo
arm group type: Placebo Comparator
description: 1 capsule of Matching Placebo orally daily for 6 months
intervention type: Dietary Supplement
intervention name: High Strength Cranberry
description: Softgel capsule
arm group label: High Strength Cranberry
other name: 25,000mg Vaccinium macrocarpon
intervention type: Dietary Supplement
intervention name: Placebo
description: Soy oil to match High Strength Cranberry Softgel Capsule
arm group label: Placebo
other name: Placebo (for High Strength Cranberry)
criteria: 
gender: Female
gender based: Yes
gender description: Females with a history of recurrent UTIs
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Welma Stonehouse, PhD
role: Principal Investigator
affiliation: Commonwealth Scientific and Industrial Research Organisation, Australia
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
sharing ipd: No