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Dietary Impact on Urinary pH in Women With Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT03041194
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Rosemary Catanzaro, RD, St. Louis University

Tracking Information
First Submitted Date January 19, 2017
First Posted Date February 2, 2017
Last Update Posted Date September 25, 2017
Actual Study Start Date January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2017)
The impact of urinary pH [ Time Frame: 1 year ]
urinary pH.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dietary Impact on Urinary pH in Women With Interstitial Cystitis
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
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population female, all backgrounds and races
Condition Interstitial Cystitis
Intervention Other: dietary affects
Dietary affects on urine pH in relation to Interstitial cystitis symptoms
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 21, 2017)
17
Original Estimated Enrollment
 (submitted: February 1, 2017)
40
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women, diagnosed with Interstitial Cystitis or with a presumptive clinical diagnosis of IC
  • New IC patients who agree to hydrodistention and cystoscopy, the standard of care for diagnosis of IC

Exclusion Criteria:

  • Subjects who are diagnosed with Fibromyalgia Syndrome and subjects that are pregnant.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03041194
Other Study ID Numbers 25300
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rosemary Catanzaro, RD, St. Louis University
Study Sponsor St. Louis University
Collaborators Not Provided
Investigators
Principal Investigator: Rosemary Catanzaro, MS RD St. Louis University
PRS Account St. Louis University
Verification Date September 2017