High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection (NCT03042273) | Clinical Trial Compass
CompletedPhase 2
High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection
Australia150 participantsStarted 2017-05-15
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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