xml: <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/NCT06013696</url>
    </required_header>
    <id_info>
      <org_study_id>MMC-22-198</org_study_id>
      <nct_id>NCT06013696</nct_id>
    </id_info>
    <brief_title>Bleach and Urine Color in UC Patients Using 5ASA</brief_title>
    <acronym>Asableach</acronym>
    <official_title>The Effect of Household Bleach on Urine Color Among Pediatric Ulcerative Colitis Patients Treated With 5-aminosalicylic Acid</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Meir Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Meir Medical Center</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>
        The aim of this study is to evaluate the effect on urine color by adding household bleach to&#xD;
        fresh urine sample among pediatric UC subjects treated with 5ASA&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to evaluate the effect on urine color by adding household bleach to&#xD;
        fresh urine sample among pediatric UC subjects treated with 5ASA.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 16, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change is urine color</measure>
      <time_frame>5 minutes</time_frame>
      <description>Following the addition of 1mL of 5% household bleach to a 10mL of each subject's urine, we will visually look for color change to red or orange within 5 minutes. Urine changing color to red or orange will be marked as a positive response to the bleach, which would fulfill the primary outcome.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>Pediatric UC subjects treated with 5ASA compunds</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Each subject will provide a fresh urine sample in an empty sterile plastic cup. Urinalysis will be performed to check for macro- or micro-hematuria or signs of infection. We will take 10mL of the urine sample and add 1mL of transparent (colorless) household bleach (≤5% sodium hypochlorite). The color of the urine before and 5 minutes after adding the bleach will be recorded.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Each subject will provide a fresh urine sample in an empty sterile plastic cup. Urinalysis will be performed to check for macro- or micro-hematuria or signs of infection. We will take 10mL of the urine sample and add 1mL of transparent (colorless) household bleach (≤5% sodium hypochlorite). The color of the urine before and 5 minutes after adding the bleach will be recorded.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Adding household bleach to urine sample</intervention_name>
      <description>Adding household bleach to urine sample</description>
      <arm_group_label>Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)</arm_group_label>
      <arm_group_label>Pediatric UC subjects treated with 5ASA compunds</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. UC patients in remission&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Acute UC exacerbation defined as Pediatric ulcerative colitis activity index (PUCAI)&#xD;
               ≥10&#xD;
  &#xD;
            2. Any acute or chronic renal disease, either present or past&#xD;
  &#xD;
            3. Chronic hypertension, either present or past&#xD;
  &#xD;
            4. Regularly receiving other medication that may cause nephrotoxicity - Non-steroidal&#xD;
               anti-inflammatory drugs, acetaminophen, anti-epileptics, and antibiotics.&#xD;
  &#xD;
            5. Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>20 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eyal Zifman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Meir Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Meir Medical Center</name>
        <address>
          <city>Kfar Saba</city>
          <zip>4464402</zip>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Meir Medical Center</investigator_affiliation>
      <investigator_full_name>eyal zifman</investigator_full_name>
      <investigator_title>Head of pediatric gastroenterology service</investigator_title>
    </responsible_party>
    <keyword>Hematuria</keyword>
    <keyword>Urine</keyword>
    <keyword>5-Aminosalycilic acid</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colitis</mesh_term>
      <mesh_term>Colitis, Ulcerative</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>According to instructions from our IRB the study&amp;#39;s IPD is not to be shared. Specific requests may be sent after the study&amp;#39;s completion and will be considered by the IRB .</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013696
  org study id: MMC-22-198
  nct id: NCT06013696
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the effect on urine color by adding household bleach to
        fresh urine sample among pediatric UC subjects treated with 5ASA
  The aim of this study is to evaluate the effect on urine color by adding household bleach to
        fresh urine sample among pediatric UC subjects treated with 5ASA.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Care Provider)
  measure: Change is urine color
  time frame: 5 minutes
  description: Following the addition of 1mL of 5% household bleach to a 10mL of each subject's urine, we will visually look for color change to red or orange within 5 minutes. Urine changing color to red or orange will be marked as a positive response to the bleach, which would fulfill the primary outcome.
  arm group label: Pediatric UC subjects treated with 5ASA compunds
  arm group type: Active Comparator
  description: Each subject will provide a fresh urine sample in an empty sterile plastic cup. Urinalysis will be performed to check for macro- or micro-hematuria or signs of infection. We will take 10mL of the urine sample and add 1mL of transparent (colorless) household bleach (≤5% sodium hypochlorite). The color of the urine before and 5 minutes after adding the bleach will be recorded.
  arm group label: Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)
  arm group type: Placebo Comparator
  description: Each subject will provide a fresh urine sample in an empty sterile plastic cup. Urinalysis will be performed to check for macro- or micro-hematuria or signs of infection. We will take 10mL of the urine sample and add 1mL of transparent (colorless) household bleach (≤5% sodium hypochlorite). The color of the urine before and 5 minutes after adding the bleach will be recorded.
  intervention type: Other
  intervention name: Adding household bleach to urine sample
  description: Adding household bleach to urine sample
  arm group label: Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)
  arm group label: Pediatric UC subjects treated with 5ASA compunds
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 20 Years
  healthy volunteers: No
  last name: Eyal Zifman, MD
  role: Principal Investigator
  affiliation: Meir Medical Center
  facility: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Meir Medical Center
  investigator full name: eyal zifman
  investigator title: Head of pediatric gastroenterology service
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Ulcer
  sharing ipd: No
  ipd description: According to instructions from our IRB the study&#39;s IPD is not to be shared. Specific requests may be sent after the study&#39;s completion and will be considered by the IRB .