NCT00318253

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

April 24, 2006

Last Update Submit

July 8, 2009

Conditions

Bacterial VaginosisOxaluria

Keywords

Cranberry juiceAntiadhesionUrinary tract infectionvaginosis

Outcome Measures

Primary Outcomes (2)

  • bacterial adhesion to tissue cells

  • microbial population shifts in vaginal tract

Interventions

cranberry juicePROCEDURE

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19-45 years
  • Healthy pre-menopausal female volunteers with no history of urinary tract infections over the past 12 months.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vaginosis, BacterialHyperoxaluriaUrinary Tract InfectionsVaginal Diseases

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Gregor Reid, PhD, MBA

    The Lawson Health Research Institute and The University of Western Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

July 9, 2009

Record last verified: 2009-07