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CompletedNCT03041194Updated Sep 25, 2017

Dietary Impact on Urinary pH in Women With Interstitial Cystitis

An observational study in Interstitial Cystitis, sponsored by St. Louis University. Completed. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by St. Louis University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years to 70 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Interstitial Cystitis
03

In context

Cystitis

235 studies on the registry are indexed under Cystitis; 22 are open to participants now.

This study's enrollment of 17 is below the median of 86 across 50 observational studies indexed under Cystitis.

Browse Cystitis studies →

Lead sponsor

St. Louis University is the lead sponsor of 152 studies on the registry; 17 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

female, all backgrounds and races

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

Exclusion Criteria:

  • Subjects who are diagnosed with Fibromyalgia Syndrome and subjects that are pregnant.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Interventions

  • Otherdietary affects

    Dietary affects on urine pH in relation to Interstitial cystitis symptoms

06

What researchers measure

Primary outcomes

  1. The impact of urinary pH

    urinary pH.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03041194
Lead sponsor
St. Louis University
Responsible party
Rosemary Catanzaro, RD (Principal Investigator, St. Louis University) — Principal investigator
First posted
Feb 2, 2017
Start date
Jan 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Sep 25, 2017

Study contacts

Rosemary Catanzaro, MS RD
principal investigator · St. Louis University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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