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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03042273




Registration number
NCT03042273
Ethics application status
Date submitted
1/02/2017
Date registered
3/02/2017
Date last updated
17/06/2019

Titles & IDs
Public title
High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection
Scientific 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)
Secondary ID [1] 0 0
PAC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Tract Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - High Strength Cranberry
Other interventions - Placebo

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

Placebo Comparator: Placebo - 1 capsule of Matching Placebo orally daily for 6 months


Other interventions: High Strength Cranberry
Softgel capsule

Other interventions: Placebo
Soy oil to match High Strength Cranberry Softgel Capsule

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of UTI - cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL)
Timepoint [1] 0 0
6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Holdsworth House Medical Centre - Sydney
Recruitment hospital [2] 0 0
Holdsworth House Medical Centre - Brisbane
Recruitment hospital [3] 0 0
Griffith University Clinical Trial Unit (Griffith Health) - Gold Coast
Recruitment hospital [4] 0 0
CSIRO Nutrition and Health Research Clinic - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4006 - Brisbane
Recruitment postcode(s) [3] 0 0
4222 - Gold Coast
Recruitment postcode(s) [4] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Swisse Wellness Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT03042273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Welma Stonehouse, PhD
Address 0 0
CSIRO
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bianca Benassi, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 8 8303 8982
Fax 0 0
Email 0 0
Bianca.Benassi@csiro.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03042273