<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/NCT03019874</url>
  </required_header>
  <id_info>
    <org_study_id>Cranberry</org_study_id>
    <nct_id>NCT03019874</nct_id>
  </id_info>
  <brief_title>Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections</brief_title>
  <official_title>Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <brief_summary>
    <textblock>
      The main focus of this observational study is to analyze the possible effects of cranberry&#xD;
      dietary supplements on the intestinal microbiota in women with recurrent uncomplicated&#xD;
      urinary tract infections. In a secondary analysis the possible influence of the microbiota&#xD;
      changes on the recurrence frequency in the follow-up should be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of urinary tract infections</measure>
    <time_frame>In the 6-month prospective observation period compared to a 6-month retrospective period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36)</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Stool analysis: Intestinal microbiome by sequencing 16S rRNA</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 6 months</time_frame>
  </other_outcome>
  <enrollment type="Actual">23</enrollment>
  <condition>Urinary Tract Infections</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cranberry Extract</intervention_name>
    <description>3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic recurrent Urinary Tract Infections&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        • chronic recurrent urinary tract infections (≥3 infections per year or 2 infections in the&#xD;
        last 6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  renal insufficiency (GFR &lt;60),&#xD;
&#xD;
          -  anatomical or known structural causes of urinary tract infections&#xD;
&#xD;
          -  regular consumption of probiotics or probiotic yogurts (at least 5x / week)&#xD;
&#xD;
          -  intake of antibiotics in the last 4 weeks&#xD;
&#xD;
          -  intake of Marcumar&#xD;
&#xD;
          -  simultaneous participation in another study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Michalsen, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charité University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Prof. Dr. Andreas Michalsen</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03019874
org study id: Cranberry
nct id: NCT03019874
lead sponsor: 
The main focus of this observational study is to analyze the possible effects of cranberry
      dietary supplements on the intestinal microbiota in women with recurrent uncomplicated
      urinary tract infections. In a secondary analysis the possible influence of the microbiota
      changes on the recurrence frequency in the follow-up should be analyzed.
observational model: Cohort
time perspective: Prospective
measure: Number of urinary tract infections
time frame: In the 6-month prospective observation period compared to a 6-month retrospective period
measure: Quality of life (SF-36)
time frame: Baseline, 4 weeks, 8 weeks, 6 months
measure: Stool analysis: Intestinal microbiome by sequencing 16S rRNA
time frame: Baseline, 4 weeks, 8 weeks, 6 months
intervention type: Dietary Supplement
intervention name: Cranberry Extract
description: 3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Andreas Michalsen, Prof. Dr.
role: Principal Investigator
affiliation: Charité University Medical Center
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Prof. Dr. Andreas Michalsen
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections