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 — DRUG
    All 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 Group
    All 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

Locations (1)

FacilityCityStateZIPSite coordinators
Loyola Medical CenterMaywoodIllinois60153
Mary Tulke, RN
7082162067

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