- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318253
The Effects of Cranberry Juice on Bacterial Adhesion
The Effects of Cranberry Juice on Urine and Bacterial Adhesion to Cells
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
bacterial adhesion to tissue cells
|
microbial population shifts in vaginal tract
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregor Reid, PhD, MBA, The Lawson Health Research Institute and The University of Western Ontario
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-06-704
- SP 0732
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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