High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection

NCT03042273 | Completed Phase 2

• 1 other identifier: PAC-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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).

Conditions

Urinary Tract Infection

Keywords

recurrent

Outcome Measures

Primary Outcomes (1)

• Incidence of UTI

  cultured confirmed UTIs at a level of \>108cfu/L (105cfu/mL)

  6 months

Study Arms (2)

High Strength Cranberry

EXPERIMENTAL

1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months

Dietary Supplement: High Strength Cranberry

Placebo

PLACEBO COMPARATOR

1 capsule of Matching Placebo orally daily for 6 months

Dietary Supplement: Placebo

Interventions

High Strength Cranberry DIETARY_SUPPLEMENT

Softgel capsule

Also known as: 25,000mg Vaccinium macrocarpon

High Strength Cranberry

Placebo DIETARY_SUPPLEMENT

Soy oil to match High Strength Cranberry Softgel Capsule

Also known as: Placebo (for High Strength Cranberry)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females with a history of recurrent UTIs
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Women of child bearing potential that have not been using effective methods of contraception for 14 days prior to Day 1
• History of or known clinically significant cardiac disease
• History of or known clinically significant liver disease
• History of or known clinically significant gastrointestinal disease
• History of or known metabolic disorder or diabetes

Sponsors & Collaborators

• Swisse Wellness Pty Ltd: lead
• Commonwealth Scientific and Industrial Research Organisation, Australia: collaborator

Study Sites (5)

Holdsworth House Medical Centre

Sydney, New South Wales, 2010, Australia

Location

Holdsworth House Medical Centre

Brisbane, Queensland, 4006, Australia

Location

Griffith University Clinical Trial Unit (Griffith Health)

Gold Coast, Queensland, 4222, Australia

Location

CSIRO Nutrition and Health Research Clinic

Adelaide, South Australia, Australia

Location

Monash Alfred Psychiatry Research Centre (MAPrc)

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Stonehouse W, Benassi-Evans B, Bednarz J, Vincent AD. Whole cranberry fruit powder supplement reduces the incidence of culture-confirmed urinary tract infections in females with a history of recurrent urinary tract infection: A 6-month multicenter, randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2025 Apr;121(4):932-941. doi: 10.1016/j.ajcnut.2025.01.022. Epub 2025 Jan 23.

  PMID: 39863114 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Recurrence

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Welma Stonehouse, PhD

  Commonwealth Scientific and Industrial Research Organisation, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: May 15, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 18, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)