Urinary Tract Infection
Conditions
Keywords
recurrent
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).
Interventions
DIETARY_SUPPLEMENTHigh Strength Cranberry
Softgel capsule
DIETARY_SUPPLEMENTPlacebo
Soy oil to match High Strength Cranberry Softgel Capsule
Sponsors
Commonwealth Scientific and Industrial Research Organisation, Australia
Swisse Wellness Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Females aged 18-65 years, inclusive 2. 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 3. Willing to answer questionnaires and comply with the study requirements 4. Ability to swallow capsules 5. Provided Written Informed Consent 6. BMI \>17.5kg m2 and \<35kg m2
Exclusion criteria
1. Microbial growth on urine culture of ≥107 cfu/L (104cfu/mL) within 7 days of Day 1 2. A history of \>5 UTIs in the last 6 months (confirmed by self-report or health professional) 3. Use of antibiotics or antibiotics for prophylaxis within 28 days of Day 1 4. 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 5. 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 6. Presence of an intermittent or indwelling urinary catheter 7. Anatomical abnormalities of the urinary tract 8. History of or known clinically significant renal or urological disease(self-reported) 9. Positive urine dipstick pregnancy test at screening onDay 1, currently pregnant and/or breastfeeding 10. Women of Childbearing potential not willing to use adequate and effective methods of contraception throughout the study 11. Women of child bearing potential that have not been using effective methods of contraception for 14 days prior to Day 1 12. History of or known clinically significant cardiac disease 13. History of or known clinically significant liver disease 14. History of or known clinically significant gastrointestinal disease 15. History of or known metabolic disorder or diabetes 16. History or presence of alcohol or illicit drug abuse,any surgical history, clinical condition or organ dysfunction that in the opinion of the Medical Investigator may affect the participant's ability to participate in the study or the study results 17. Currently hospitalised or any planned hospitalisations within 1 month following the last dose of study product 18. Immunocompromised participants or participants receiving immunosuppressive medication 19. History of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients 20. Currently taking warfarin or has received Warfarin within 28 days of Day 1 21. Received an investigational drug within 28 days of Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of UTI | 6 months | cultured confirmed UTIs at a level of \>108cfu/L (105cfu/mL) |
Countries
Australia
Outcome results
None listed