Bacterial VaginosisNCT00318253
The Effects of Cranberry Juice on Bacterial Adhesion
A study testing cranberry juice in people with Bacterial Vaginosis and Oxaluria, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis, Oxaluria
- What is being tested?
- cranberry juice
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19-45 years
- Healthy pre-menopausal female volunteers with no history of urinary tract infections over the past 12 months.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Bacterial Vaginosis, Oxaluria
- Being tested
- cranberry juice
- Keywords
- Cranberry juice, Antiadhesion, Urinary tract infection, vaginosis
- Medical subject headings
- Vaginosis, Bacterial, Hyperoxaluria, Urinary Tract Infections, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranberry juiceProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial adhesion to tissue cells
microbial population shifts in vaginal tract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Gregor Reid, PhD, MBA, Principal investigator, The Lawson Health Research Institute and The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318253
- Sponsor's protocol ID
- R-06-704
- Other IDs
- SP 0732
- Status last verified
- Jul 2009
- First submitted
- 24 Apr 2006
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cranberry Juice on Urine and Bacterial Adhesion to Cells
- ClinicalTrials.gov ID
- NCT00318253
- Acronym / sponsor ID
- R-06-704
- Conditions
- Bacterial Vaginosis, Oxaluria
- Keywords
- Cranberry juice, Antiadhesion, Urinary tract infection, vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Mar 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 26 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 19-45 years
- Healthy pre-menopausal female volunteers with no history of urinary tract infections over the past 12 months.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cranberry juice | Procedure or surgery | – |
Primary outcome
bacterial adhesion to tissue cells
microbial population shifts in vaginal tract
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Reid, PhD, MBA principal investigator
The Lawson Health Research Institute and The University of Western Ontario
Questions about this trial
What is this clinical trial studying?
A study testing cranberry juice in people with Bacterial Vaginosis and Oxaluria, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial adhesion to tissue cells. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2009.