High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection

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)

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).

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Dietary supplement: High Strength Cranberry; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Centre
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Holdsworth House Medical Centre
    • Gold Coast, Queensland, Australia, 4222
      • Griffith University Clinical Trial Unit (Griffith Health)
  • South Australia
    • Adelaide, South Australia, Australia
      • CSIRO Nutrition and Health Research Clinic
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Monash Alfred Psychiatry Research Centre (MAPrc)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Strength Cranberry; 1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months	Dietary supplement: High Strength Cranberry; Softgel capsule; Other Names: 25,000mg Vaccinium macrocarpon
Placebo Comparator: Placebo; 1 capsule of Matching Placebo orally daily for 6 months	Dietary supplement: Placebo; Soy oil to match High Strength Cranberry Softgel Capsule; Other Names: Placebo (for High Strength Cranberry)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of UTI	cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL)	6 months

Collaborators and Investigators

• Sponsor: Swisse Wellness Pty Ltd
• Collaborators: Commonwealth Scientific and Industrial Research Organisation, Australia
• Investigators: Principal Investigator: Welma Stonehouse, PhD, Commonwealth Scientific and Industrial Research Organisation, Australia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: recurrent
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: PAC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No