Urinary Tract InfectionPhase 2NCT03042273
High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection
A Phase 2 study testing High Strength Cranberry in people with Urinary Tract Infection, run by Swisse Wellness Pty Ltd at 5 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- High Strength Cranberry
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 5 sitesAustralia
- Study dates
- 15 May 2017to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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
- Currently hospitalised or any planned hospitalisations within 1 month following the last dose of study product
- Immunocompromised participants or participants receiving immunosuppressive medication
- History of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients
- Currently taking warfarin or has received Warfarin within 28 days of Day 1
- Received an investigational drug within 28 days of Day 1
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
CSIRO Nutrition and Health Research Clinic
Adelaide, South Australia
Holdsworth House Medical Centre
Brisbane, Queensland, 4006
Griffith University Clinical Trial Unit (Griffith Health)
Gold Coast, Queensland, 4222
Monash Alfred Psychiatry Research Centre (MAPrc)
Melbourne, Victoria, 3004
Holdsworth House Medical Centre
Sydney, New South Wales, 2010
About this study
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)
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
- Being tested
- High Strength Cranberry, Placebo
- Keywords
- recurrent
- Medical subject headings
- Urinary Tract Infections, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Strength CranberryDietary supplement
Also called 25,000mg Vaccinium macrocarpon
Softgel capsule
PlaceboDietary supplement
Also called Placebo (for High Strength Cranberry)
Soy oil to match High Strength Cranberry Softgel Capsule
| Study group | Role | What they receive |
|---|---|---|
| High Strength Cranberry | Experimental | 1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months Receives: Dietary Supplement: High Strength Cranberry |
| Placebo | Placebo comparator | 1 capsule of Matching Placebo orally daily for 6 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of UTI
cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start15 May 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swisse Wellness Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Commonwealth Scientific and Industrial Research Organisation, Australia
- Responsible party
- Sponsor
- Investigators
- Welma Stonehouse, PhD, Principal investigator, Commonwealth Scientific and Industrial Research Organisation, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042273
- Sponsor's protocol ID
- PAC-001
- Status last verified
- Jun 2019
- First submitted
- 1 Feb 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39863114
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03042273
- Acronym / sponsor ID
- PAC-001
- Conditions
- Urinary Tract Infection
- Keywords
- recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Swisse Wellness Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Commonwealth Scientific and Industrial Research Organisation, Australia
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Strength Cranberry | Experimental | Dietary Supplement: High Strength Cranberry1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule of Matching Placebo orally daily for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Strength CranberryAlso: 25,000mg Vaccinium macrocarponSoftgel capsule | Dietary supplement | High Strength Cranberry |
| PlaceboAlso: Placebo (for High Strength Cranberry)Soy oil to match High Strength Cranberry Softgel Capsule | Dietary supplement | Placebo |
Primary outcome
Incidence of UTI
Time frame: 6 months
cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 39863114Stonehouse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Welma Stonehouse, PhD principal investigator
Commonwealth Scientific and Industrial Research Organisation, Australia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Strength Cranberry in people with Urinary Tract Infection, run by Swisse Wellness Pty Ltd at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of UTI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.