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The Effects of Cranberry Juice on Bacterial Adhesion
This study has been completed.
Study NCT00318253   Information provided by Lawson Health Research Institute
First Received: April 24, 2006   Last Updated: July 8, 2009   History of Changes

April 24, 2006
July 8, 2009
March 2006
August 2006   (final data collection date for primary outcome measure)
  • bacterial adhesion to tissue cells
  • microbial population shifts in vaginal tract [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00318253 on ClinicalTrials.gov Archive Site
 
 
 
The Effects of Cranberry Juice on Bacterial Adhesion
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.

 
Interventional
Prevention, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
  • Bacterial Vaginosis
  • Oxaluria
Procedure: cranberry juice
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
12
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Female
19 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00318253
Dr. G. Reid, Lawson Health Research Institute
R-06-704, SP 0732
Lawson Health Research Institute
Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Gregor Reid, PhD, MBA The Lawson Health Research Institute and The University of Western Ontario
Lawson Health Research Institute
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP