Last updated: August 19, 2022
Sponsor: University of Louisville
Overall Status: Active - Recruiting
Phase
1/2
Condition
Interstitial Cystitis
Gynecological Infections
Urinary Tract Infections
Treatment
N/AClinical Study ID
NCT04845217
21.0286
Ages 18-65 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women ages 18-65 years old
- Diagnosed with IC/BPS for at least one month prior to study enrollment
Exclusion
Exclusion Criteria:
- Culture proven urinary tract infection within 1 month of randomization
- Gross hematuria
- Currently pregnant or breastfeeding
- Unable to speak and read English
- History of allergic reaction to peppermint, coconut or enteric coating
- History of malabsorption syndrome
- History of gastroparesis
- History of gastric bypass surgery
- History of gastrointestinal, genitourinary or pelvic cancer in the last 5 years
- History of insulin dependent diabetes
- History of active urinary stone disease
Study Design
Total Participants: 100
Study Start date:
September 15, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Springs Medical Center
Louisville, Kentucky 40205
United StatesActive - Recruiting
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