<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/NCT03041194</url>
  </required_header>
  <id_info>
    <org_study_id>25300</org_study_id>
    <nct_id>NCT03041194</nct_id>
  </id_info>
  <brief_title>Dietary Impact on Urinary pH in Women With Interstitial Cystitis</brief_title>
  <official_title>Title A Pilot Study to Evaluate the Dietary Impact on Urinary pH in Interstitial Cystitis Pilot Study to Evaluate the Dietary Impact on Urinary pH in Interstitial Cystitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study on subjects who suffer from Interstitial Cystitis (IC) to assess the&#xD;
      dietary affects on urine pH in relation to their symptoms. The goal of this pilot study is to&#xD;
      determine which foods/beverages affect urinary pH and exacerbate patient's symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interstitial cystitis or painful bladder syndrome is a condition that is chronic and often&#xD;
      debilitating in nature. Interstitial cystitis is commonly defined by symptoms of urinary&#xD;
      urgency and frequency associated with pelvic pain. Around one million men and women in the&#xD;
      United States and Europe suffer from this condition. The diagnosis of Interstitial Cystitis&#xD;
      is one of exclusion based on cystoscopy findings and clinical symptoms. Common symptoms of&#xD;
      Interstitial Cystitis include urinary frequency, urinary urgency, dysuria, and pain in the&#xD;
      lower abdominal region, bladder, vagina, urethra, or in the perinea . Women between ages 40&#xD;
      and 60 are the most commonly affect by Interstitial Cystitis. In the Nurses' Healthy Study I&#xD;
      and II the prevalence of Interstitial Cystitis was 52-67 individuals out of 100,000. There is&#xD;
      no single cause of Interstitial Cystitis however, there are several known theories to the&#xD;
      cause of Interstitial Cystitis. A popular hypothesis is that a defect in the&#xD;
      glycosaminoglycan layer of the bladder epithelium allows leakage and absorption of urinary&#xD;
      solutes. The major solute that is responsible for causing bladder symptoms when the&#xD;
      epithelium is injured is potassium. The long held notion is that patients with Interstitial&#xD;
      Cystitis should avoid acidic foods. This logic is largely based on anecdotal data and&#xD;
      questionnaires of foods, beverages and supplements that increase symptoms. Controversy exists&#xD;
      that Interstitial Cystitis diet restricts many more foods than necessary in an attempt to&#xD;
      decrease Interstitial Cystitis symptoms. Current questionnaires-based data suggest&#xD;
      eliminating tomatoes, citrus fruits, vitamin C, artificial sweeteners, carbonated and&#xD;
      alcoholic beverages, and spicy foods which are thought to exacerbate symptoms, while calcium&#xD;
      glycerophosphate and sodium bicarbonate may improve symptoms. Though the literature review,&#xD;
      the investigators did not find any analytical studies that correlated diet with Interstitial&#xD;
      Cystitis symptoms or that the ingestion of acidic foods exacerbate Interstitial Cystitis&#xD;
      symptoms. Based on the lack of analytical data and the impact of acidic food on IC symptoms&#xD;
      this study is going to evaluate the potential renal acid load and net acid excretion of foods&#xD;
      to determine which foods change urinary pH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>The impact of urinary pH</measure>
    <time_frame>1 year</time_frame>
    <description>urinary pH.</description>
  </primary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Interstitial Cystitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dietary affects</intervention_name>
    <description>Dietary affects on urine pH in relation to Interstitial cystitis symptoms</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        female, all backgrounds and races&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, diagnosed with Interstitial Cystitis or with a presumptive clinical diagnosis&#xD;
             of IC&#xD;
&#xD;
          -  New IC patients who agree to hydrodistention and cystoscopy, the standard of care for&#xD;
             diagnosis of IC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are diagnosed with Fibromyalgia Syndrome and subjects that are pregnant.&#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>Rosemary Catanzaro, MS RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Rosemary Catanzaro, RD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</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/NCT03041194
org study id: 25300
nct id: NCT03041194
lead sponsor: 
has dmc: No
This is a pilot study on subjects who suffer from Interstitial Cystitis (IC) to assess the
      dietary affects on urine pH in relation to their symptoms. The goal of this pilot study is to
      determine which foods/beverages affect urinary pH and exacerbate patient's symptoms.
Interstitial cystitis or painful bladder syndrome is a condition that is chronic and often
      debilitating in nature. Interstitial cystitis is commonly defined by symptoms of urinary
      urgency and frequency associated with pelvic pain. Around one million men and women in the
      United States and Europe suffer from this condition. The diagnosis of Interstitial Cystitis
      is one of exclusion based on cystoscopy findings and clinical symptoms. Common symptoms of
      Interstitial Cystitis include urinary frequency, urinary urgency, dysuria, and pain in the
      lower abdominal region, bladder, vagina, urethra, or in the perinea . Women between ages 40
      and 60 are the most commonly affect by Interstitial Cystitis. In the Nurses' Healthy Study I
      and II the prevalence of Interstitial Cystitis was 52-67 individuals out of 100,000. There is
      no single cause of Interstitial Cystitis however, there are several known theories to the
      cause of Interstitial Cystitis. A popular hypothesis is that a defect in the
      glycosaminoglycan layer of the bladder epithelium allows leakage and absorption of urinary
      solutes. The major solute that is responsible for causing bladder symptoms when the
      epithelium is injured is potassium. The long held notion is that patients with Interstitial
      Cystitis should avoid acidic foods. This logic is largely based on anecdotal data and
      questionnaires of foods, beverages and supplements that increase symptoms. Controversy exists
      that Interstitial Cystitis diet restricts many more foods than necessary in an attempt to
      decrease Interstitial Cystitis symptoms. Current questionnaires-based data suggest
      eliminating tomatoes, citrus fruits, vitamin C, artificial sweeteners, carbonated and
      alcoholic beverages, and spicy foods which are thought to exacerbate symptoms, while calcium
      glycerophosphate and sodium bicarbonate may improve symptoms. Though the literature review,
      the investigators did not find any analytical studies that correlated diet with Interstitial
      Cystitis symptoms or that the ingestion of acidic foods exacerbate Interstitial Cystitis
      symptoms. Based on the lack of analytical data and the impact of acidic food on IC symptoms
      this study is going to evaluate the potential renal acid load and net acid excretion of foods
      to determine which foods change urinary pH.
observational model: Cohort
time perspective: Prospective
measure: The impact of urinary pH
time frame: 1 year
description: urinary pH.
intervention type: Other
intervention name: dietary affects
description: Dietary affects on urine pH in relation to Interstitial cystitis symptoms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rosemary Catanzaro, MS RD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Rosemary Catanzaro, RD
investigator title: Principal Investigator
mesh term: Cystitis
mesh term: Cystitis, Interstitial
sharing ipd: No