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
About this trial
This is an interventional prevention trial for Bacterial Vaginosis focused on measuring Cranberry juice, Antiadhesion, Urinary tract infection, vaginosis
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
Sites / Locations
Outcomes
Primary Outcome Measures
bacterial adhesion to tissue cells
microbial population shifts in vaginal tract
Secondary Outcome Measures
Full Information
NCT ID
NCT00318253
First Posted
April 24, 2006
Last Updated
July 8, 2009
Sponsor
Lawson Health Research Institute
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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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