High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Dietary Supplement: High Strength Cranberry
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Strength Cranberry<br>1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months | Dietary Supplement: High Strength Cranberry<br>* Softgel capsule<br>* Other names: 25,000mg Vaccinium macrocarpon;|
| Placebo Comparator: Placebo<br>1 capsule of Matching Placebo orally daily for 6 months | Dietary Supplement: Placebo<br>* Soy oil to match High Strength Cranberry Softgel Capsule<br>* Other names: Placebo (for High Strength Cranberry);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of UTI | cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent