Clinical trial NCT03042273: High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infection
Keywords: recurrent
Lead sponsor: Swisse Wellness Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Commonwealth Scientific and Industrial Research Organisation, Australia
First posted: 2017-02-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of UTI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Holdsworth House Medical Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Holdsworth House Medical Centre
state: Queensland
city: Gold Coast
country: Australia
facility: Griffith University Clinical Trial Unit (Griffith Health)
state: Queensland
city: Adelaide
country: Australia
facility: CSIRO Nutrition and Health Research Clinic
state: South Australia
city: Melbourne
country: Australia
facility: Monash Alfred Psychiatry Research Centre (MAPrc)
state: Victoria
Study officials:
affiliation: Commonwealth Scientific and Industrial Research Organisation, Australia
name: Welma Stonehouse, PhD
role: PRINCIPAL_INVESTIGATOR
References: