Recruiting

Cranberry

Sponsor:

University of British Columbia

Code:

NCT02454309

Conditions

Urinary Tract Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cranberry concentrate

Placebo

Study Details

Brief summary:

This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women. Approximately 150 adult women will be recruited to participate in this study. Subjects will be randomized to either the cranberry supplement or placebo treatment for 12 months. Subjects and investigators will be blinded to which supplement they are taking.

Conditions

Urinary Tract Infection

Study ID

NCT02454309

Start date

Jul, 2015

Status verified date

May, 2016

Completion date

Mar, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding
  • Can communicate in English

Exclusion Criteria:

  • Current UTI
  • Pregnant or breastfeeding or planning a pregnancy in the next 12 months
  • known allergy or intolerance to cranberry-containing products
  • A history of renal stones and/or renal transplantation
  • Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
  • Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
  • Intermittent or indwelling catheterization
  • Any anatomic abnormalities of the urinary tract
  • The use of any antibiotics within 2 weeks before study entry
  • The use of any natural health products, including herbs, homeopathic products, or other forms of cranberry supplements within 2 weeks before study entry

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cranberry concentrate

Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate)

placebo comparator: Placebo

A capsule containing control formulation

Interventions

Cranberry concentrate

Placebo

Primary outcome measure

  • Number of urinary tract infections [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sarah J Harvey, MSc

6047542245sarah.harvey@ubc.ca

Locations

The University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z4

Principal Investigator:

Tim Green, PhD

More Information

Sponsor

University of British Columbia

Last update posted

Jun 1, 2016

Last verified

May, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-06-01.