NCT03041194

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

January 19, 2017

Last Update Submit

September 21, 2017

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

  • The impact of urinary pH

    urinary pH.

    1 year

Interventions

dietary affectsOTHER

Dietary affects on urine pH in relation to Interstitial cystitis symptoms

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female, all backgrounds and races

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Rosemary Catanzaro, MS RD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2017

First Posted

February 2, 2017

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share