Bacterial Vaginosis Clinical Trial
Official title:
The Effects of Cranberry Juice on Urine and Bacterial Adhesion to Cells
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.
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:
1. Water - Control group
2. Cranberry juice 1/day
3. Cranberry juice 2/day
4. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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