A Randomised, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of High Strength Cranberry (Pacran®) in Women With Recurrent Urinary Tract Infections (Cystitis)

Swisse Wellness Pty Ltd4 sites in 1 country150 target enrollmentMay 15, 2017

ConditionsUrinary Tract Infection

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Urinary Tract Infection
Sponsor: Swisse Wellness Pty Ltd
Enrollment: 150
Locations: 4
Primary Endpoint: Incidence of UTI
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).

Registry

clinicaltrials.gov

Start Date

May 15, 2017

End Date

December 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Swisse Wellness Pty Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Females aged 18-65 years, inclusive
•A history of recurrent urinary tract infection defined as ≥3 UTIs in the last year OR at least 2 UTIs occurring in the last 6 months. Each infection requires confirmation by a health professional
•Willing to answer questionnaires and comply with the study requirements
•Ability to swallow capsules
•Provided Written Informed Consent
•BMI \>17.5kg m2 and \<35kg m2

Exclusion Criteria

•Microbial growth on urine culture of ≥107 cfu/L (104cfu/mL) within 7 days of Day 1
•A history of \>5 UTIs in the last 6 months (confirmed by self-report or health professional)
•Use of antibiotics or antibiotics for prophylaxis within 28 days of Day 1
•Use of any antibacterial products, that in the opinion of the Medical Investigator may interfere with the study outcomes, within 28 days of Day 1
•Regular use of Vaccinium containing products (e.g. all forms of blueberries, cranberries, bilberry, lingonberry , etc i.e fruit, dried fruit, pills, juices or supplements) within 28 days of Day 1 at the discretion of the Medical Investigator
•Presence of an intermittent or indwelling urinary catheter
•Anatomical abnormalities of the urinary tract
•History of or known clinically significant renal or urological disease(self-reported)
•Positive urine dipstick pregnancy test at screening onDay 1, currently pregnant and/or breastfeeding
•Women of Childbearing potential not willing to use adequate and effective methods of contraception throughout the study