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The Effects of Cranberry Juice on Bacterial Adhesion

Primary Purpose

Bacterial Vaginosis, Oxaluria

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cranberry juice
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring Cranberry juice, Antiadhesion, Urinary tract infection, vaginosis

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age 19-45 years Healthy pre-menopausal female volunteers with no history of urinary tract infections over the past 12 months. Exclusion Criteria: Experienced a urinary tract infection in the past 12 months Receiving antibiotic therapy or supplements to prevent urinary tract infections Pregnant, postmenopausal or outside of the age range (19-45 years old) Anatomical abnormality of the urinary tract, such as following surgery Using a catheter to manage micturition Diabetic Allergic to berry juices

Sites / Locations

    Outcomes

    Primary Outcome Measures

    bacterial adhesion to tissue cells
    microbial population shifts in vaginal tract

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2006
    Last Updated
    July 8, 2009
    Sponsor
    Lawson Health Research Institute
    Collaborators
    Otsuka Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00318253
    Brief Title
    The Effects of Cranberry Juice on Bacterial Adhesion
    Official Title
    The Effects of Cranberry Juice on Urine and Bacterial Adhesion to Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Lawson Health Research Institute
    Collaborators
    Otsuka Pharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is based on the hypothesis that consumption of cranberry juice products results in the production of metabolites in the urine that have anti-adhesive properties on bacteria. A crossover study using 12 healthy women will be given different cranberry products or water as a control and their urine will be analyzed for anti-adhesive effects and compared to the properties of the urine. Cranberry juice will also be evaluated for its effect on vaginal microflora.
    Detailed Description
    Hypothesis: Metabolites in cranberry juice, have anti-adhesive properties for uropathogenic bacteria but they do not disturb the normal vaginal flora. Study design and assays: A crossover study design using 12 healthy women will be conducted for 50 days. The anti-adhesive properties of the urine will be determined using uropathogens and changes in the vaginal microflora will be evaluated. Participants: The subjects will be healthy premenopausal women aged 19-45, who have no history of chronic urinary tract infection or have had a urinary tract infection in the past 12 months, and are currently not taking antibiotics or any supplements to prevent UTI, including cranberry juice. The subjects must not have urinary tract abnormalities, requiring catheterization for micturition, be pregnant, or diabetic or have allergies to berry juices. Each test phase is 1 week (7 days) and the following protocol will be followed: Subjects 1-3 Test phase I: water; washout phase Test phase II: cranberries; washout phase Test phase III: cranberry juice- 1/day; washout phase Test phase IV: cranberry juice- 2/day 4-6 Test phase I: cranberry juice- 2/day; washout phase Test phase II: water; washout phase Test phase III: cranberries; washout phase Test phase IV: cranberry juice- 1/day 7-9 Test phase I: cranberry juice- 1/day; washout phase Test phase II: cranberry juice- 2/day; washout phase Test phase III: water; washout phase Test phase IV: cranberries 10-12 Test phase I: cranberries; washout phase Test phase II: cranberry juice- 1/day; washout phase Test phase III: cranberry juice- 2/day; washout phase Test phase IV: water During the washout period, the subjects will return to their normal diet with no added beverage or food, although again no cranberry juice can be consumed. The beverages/food to be taken for the 7 day phases comprise: Water - Control group Cranberry juice 1/day Cranberry juice 2/day Cranberries (dried) Regime and sampling: A mid stream urine sample will be collected to evaluate the anti-adhesive effects of the various treatments. Mid stream urine will also be collected to evaluate anti-adhesive properties of the urine, and determine if changes occur following washout. A 24 h urine will be collected after 3-4 days of each phase for urinalysis. Vaginal swabs will be collected to determine the effect, if any, of the foods on the composition of the vaginal microflora.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Vaginosis, Oxaluria
    Keywords
    Cranberry juice, Antiadhesion, Urinary tract infection, vaginosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    cranberry juice
    Primary Outcome Measure Information:
    Title
    bacterial adhesion to tissue cells
    Title
    microbial population shifts in vaginal tract

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 19-45 years Healthy pre-menopausal female volunteers with no history of urinary tract infections over the past 12 months. Exclusion Criteria: Experienced a urinary tract infection in the past 12 months Receiving antibiotic therapy or supplements to prevent urinary tract infections Pregnant, postmenopausal or outside of the age range (19-45 years old) Anatomical abnormality of the urinary tract, such as following surgery Using a catheter to manage micturition Diabetic Allergic to berry juices
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregor Reid, PhD, MBA
    Organizational Affiliation
    The Lawson Health Research Institute and The University of Western Ontario
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Cranberry Juice on Bacterial Adhesion

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