Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks
Part of paid clinical trials in Maywood, Illinois.
- Sponsor
- Loyola University
- Study ID
- NCT05557279
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Overactive Bladder
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- 500 mg NDS-446 — DRUGAll participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment
Study Details
The purpose of this study is to learn about how the use of 500 mg of dried cranberry powder extract (NDS-446) changes the bacteria that normal reside in the bladder of women who don't have urinary leakage problems but do have problems with urinary urgency and frequency.
Key Dates
- Start date
- Jan 1, 2023
- Status verified
- Mar 2025
- Primary completion
- Dec 1, 2025
- Completion
- Dec 1, 2025
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Intervention GroupAll participants will receive 500 mg NDS-446 daily for 12 weeks
Primary Outcome Measure
Compare the UG microbiota (vagina, peri-urethral, catheterized and voided urine) of female participants with urgency-frequency syndrome after 12 weeks of daily use of 500 mg of NDS-446 to the UG microbiota at baseline. [ Time Frame: 12 week visit ]
Central Contacts
- Mary Tulke, RN708-216-2186
- Elizabeth Mueller, MD708-216-2170
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Loyola Medical Center | Maywood | Illinois | 60153 |
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