<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/NCT01696227</url>
  </required_header>
  <id_info>
    <org_study_id>IRB12-00279</org_study_id>
    <nct_id>NCT01696227</nct_id>
  </id_info>
  <brief_title>Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children</brief_title>
  <acronym>Nissle 1917</acronym>
  <official_title>Targeted Pathogen Replacement With Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thrasher Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children.&#xD;
      Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure,&#xD;
      pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has&#xD;
      not shown improvement of the risk of these diseases, and contributes to the growing public&#xD;
      health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the&#xD;
      bowel. In an effort to reduce the number of UTIs, investigators want to exchange the bacteria&#xD;
      living in our bowels for a more harmless variety.&#xD;
&#xD;
      Hypothesis and specific aims:&#xD;
&#xD;
      Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel&#xD;
      bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing frequency&#xD;
      of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract&#xD;
      problems that require use of catheters to empty their bladders.&#xD;
&#xD;
      Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species,&#xD;
      Enterococcus species, and Klebsiella species to live in the same environment with the&#xD;
      probiotic bacteria to see how the numbers of each bacteria change.&#xD;
&#xD;
      Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge&#xD;
      them to live in the same environment as the probiotic bacteria.&#xD;
&#xD;
      Potential Impact:&#xD;
&#xD;
      This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless&#xD;
      bacteria and reduces the use of antibiotics overall in the community.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens</measure>
    <time_frame>2 years</time_frame>
    <description>Uropathogens obtained from discarded clinical samples will be challenged to live in the same environment as the probiotic, Nissle 1917. Colonies of uropathogens and Nissle 1917 will be counted as a measure of the more successful organism as well as, zone of inhibition will be measured in co-cultures.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Recurrent UTIs</condition>
  <condition>Catheter-Related Infections</condition>
  <arm_group>
    <arm_group_label>Nissle 1917</arm_group_label>
    <description>In vitro, Nissle 1917's ability to adversely affect the growth of uropathogens associated with urinary catheters and those with a known GI resevoir will be measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nissle 1917</intervention_name>
    <description>Uropathogens will be challenged to share the same in vitro environment with Nissle 1917.</description>
    <arm_group_label>Nissle 1917</arm_group_label>
    <other_name>Probiotic</other_name>
    <other_name>Mutaflor</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bacteria recovered from samples will be retained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with urinary catheters that will be getting them removed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with urinary catheters placed that will be getting them removed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's currently getting treated for UTI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth J Lucas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>October 13, 2014</last_update_submitted>
  <last_update_submitted_qc>October 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Elizabeth Lucas</investigator_full_name>
    <investigator_title>Fellow MD</investigator_title>
  </responsible_party>
  <keyword>Nissle 1917</keyword>
  <keyword>Probiotic</keyword>
  <keyword>Uropathogen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Catheter-Related Infections</mesh_term>
    <mesh_term>Urinary Tract Infections</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/NCT01696227
org study id: IRB12-00279
nct id: NCT01696227
lead sponsor: 
collaborator: 
has dmc: No
Background:

      Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children.
      Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure,
      pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has
      not shown improvement of the risk of these diseases, and contributes to the growing public
      health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the
      bowel. In an effort to reduce the number of UTIs, investigators want to exchange the bacteria
      living in our bowels for a more harmless variety.

      Hypothesis and specific aims:

      Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel
      bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing frequency
      of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract
      problems that require use of catheters to empty their bladders.

      Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species,
      Enterococcus species, and Klebsiella species to live in the same environment with the
      probiotic bacteria to see how the numbers of each bacteria change.

      Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge
      them to live in the same environment as the probiotic bacteria.

      Potential Impact:

      This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless
      bacteria and reduces the use of antibiotics overall in the community.
time perspective: Prospective
measure: Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens
time frame: 2 years
description: Uropathogens obtained from discarded clinical samples will be challenged to live in the same environment as the probiotic, Nissle 1917. Colonies of uropathogens and Nissle 1917 will be counted as a measure of the more successful organism as well as, zone of inhibition will be measured in co-cultures.
arm group label: Nissle 1917
description: In vitro, Nissle 1917's ability to adversely affect the growth of uropathogens associated with urinary catheters and those with a known GI resevoir will be measured.
intervention type: Drug
intervention name: Nissle 1917
description: Uropathogens will be challenged to share the same in vitro environment with Nissle 1917.
arm group label: Nissle 1917
other name: Probiotic
other name: Mutaflor
Bacteria recovered from samples will be retained
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth J Lucas, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Elizabeth Lucas
investigator title: Fellow MD
mesh term: Catheter-Related Infections
mesh term: Urinary Tract Infections
mesh term: Recurrence