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The Effects of Cranberry Juice on Bacterial Adhesion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00318253
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : July 9, 2009
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE April 24, 2006
First Posted Date  ICMJE April 26, 2006
Last Update Posted Date July 9, 2009
Study Start Date  ICMJE March 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2009)
  • bacterial adhesion to tissue cells
  • microbial population shifts in vaginal tract
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2006)
  • bacterial agglutination
  • bacterial adhesion to tissue cells
  • microbial population shifts in vaginal tract
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Cranberry Juice on Bacterial Adhesion
Official Title  ICMJE The Effects of Cranberry Juice on Urine and Bacterial Adhesion to Cells
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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Bacterial Vaginosis
  • Oxaluria
Intervention  ICMJE Procedure: cranberry juice
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2006)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00318253
Other Study ID Numbers  ICMJE R-06-704
SP 0732
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. G. Reid, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Gregor Reid, PhD, MBA The Lawson Health Research Institute and The University of Western Ontario
PRS Account Lawson Health Research Institute
Verification Date July 2009

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