Title

High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection
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)
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    cranberry ...
  • Study Participants

    150
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 Started
May 15
2017
Primary Completion
Dec 31
2019
Study Completion
Dec 31
2019
Last Update
Mar 18
2020

Dietary Supplement High Strength Cranberry

Softgel capsule

  • Other names: 25,000mg Vaccinium macrocarpon

Dietary Supplement Placebo

Soy oil to match High Strength Cranberry Softgel Capsule

  • Other names: Placebo (for High Strength Cranberry)

High Strength Cranberry Experimental

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

Placebo Placebo Comparator

1 capsule of Matching Placebo orally daily for 6 months

Criteria

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
No Results Posted