Urinary Tract InfectionPhase 2NCT00100061
Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
A Phase 2 study testing Cranberry juice in people with Urinary Tract Infection, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in Canada.
Trial summary
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs). Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Cranberry juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Jul 2013
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least two UTIs in the year prior to study entry
- Willing to use acceptable methods of contraception
- Willing to refrain from consuming other forms of cranberry supplementation
Who cannot join
- Current UTI
- Allergy to cranberry-containing products
- Active urinary stone disease
- Insulin-dependent diabetes
- Immunosuppressive disease
- Current corticosteroid use
- Intermittent or indwelling catheterization
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Bladder Care Centre, University of British Columbia
Vancouver, British Columbia, V6T 2B5
About this study
Official title: Dose Response to Cranberry of Women With Recurrent UTIs
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).
Read the detailed description
Although cranberry-containing products are commonly taken to prevent UTIs and other urinary symptoms, an optimally effective dose has not been established, and the chemicals responsible for the UTI-preventing properties in cranberry-containing products have yet to be determined. This study will determine the minimum dose of cranberry-containing product necessary to prevent UTIs, the effectiveness of cranberry-containing products in fighting different strains of E. coli, and the long-term effects of cranberry-containing product consumption. This study will also determine whether plant pigments called proanthocyanidins influence the UTI-preventing properties of cranberry-containing products.
This study will last 2 years. Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year. Some participants will receive cranberry or placebo supplement tablets; others will receive cranberry juice or a placebo beverage. Clinic visits will occur every 2 months; urine collection will occur at each visit. Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1, 3, 5 and 7.
Laboratory tests will be used to assess participants during the study. A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study. Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred.
- Conditions
- Urinary Tract Infection
- Being tested
- Cranberry juice, Placebo cranberry juice
- Keywords
- Cranberry, Vaccinium macrocarpon
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry juiceDrug
liquid juice taken daily
Cranberry JuiceDietary supplement
Taken orally
Placebo cranberry juiceDietary supplement
Placebo comparitor
| Study group | Role | What they receive |
|---|---|---|
| Cranberry Juice | Active comparator | Cranberry Juice provided by Ocean Spray Receives: Drug: Cranberry juice; Dietary Supplement: Cranberry Juice |
| Placebo cranberry juice | Placebo comparator | Taken orally Receives: Dietary Supplement: Placebo cranberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
recurrence of UTI
Measured: end of study
Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)
comparison of UTI occurrence
Measured: end of study
Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
recurrence of UTI and lab results
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2004 (estimated)
- Study startMay 2007
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Lynn Stothers, MD, Principal investigator, Bladder Care Centre, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100061
- Sponsor's protocol ID
- R01AT002090-01
- Status last verified
- Mar 2013
- First submitted
- 22 Dec 2004
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
PubMed 37947276Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
PubMed 37068952
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response to Cranberry of Women With Recurrent UTIs
- ClinicalTrials.gov ID
- NCT00100061
- Acronym / sponsor ID
- R01AT002090-01
- Conditions
- Urinary Tract Infection
- Keywords
- Cranberry, Vaccinium macrocarpon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Study start
- May 2007
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 23 Dec 2004 (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 purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).
Detailed description
Although cranberry-containing products are commonly taken to prevent UTIs and other urinary symptoms, an optimally effective dose has not been established, and the chemicals responsible for the UTI-preventing properties in cranberry-containing products have yet to be determined. This study will determine the minimum dose of cranberry-containing product necessary to prevent UTIs, the effectiveness of cranberry-containing products in fighting different strains of E. coli, and the long-term effects of cranberry-containing product consumption. This study will also determine whether plant pigments called proanthocyanidins influence the UTI-preventing properties of cranberry-containing products.
This study will last 2 years. Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year. Some participants will receive cranberry or placebo supplement tablets; others will receive cranberry juice or a placebo beverage. Clinic visits will occur every 2 months; urine collection will occur at each visit. Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1, 3, 5 and 7.
Laboratory tests will be used to assess participants during the study. A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study. Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry Juice | Active comparator | Drug: Cranberry juice, Dietary Supplement: Cranberry JuiceCranberry Juice provided by Ocean Spray |
| Placebo cranberry juice | Placebo comparator | Dietary Supplement: Placebo cranberry juiceTaken orally |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least two UTIs in the year prior to study entry
- Willing to use acceptable methods of contraception
- Willing to refrain from consuming other forms of cranberry supplementation
Key exclusion criteria (8 listed)
- Current UTI
- Allergy to cranberry-containing products
- Active urinary stone disease
- Insulin-dependent diabetes
- Immunosuppressive disease
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 juiceliquid juice taken daily | Drug | Cranberry Juice |
| Cranberry JuiceTaken orally | Dietary supplement | Cranberry Juice |
| Placebo cranberry juicePlacebo comparitor | Dietary supplement | Placebo cranberry juice |
Primary outcome
Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
Time frame: end of study
recurrence of UTI
Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)
Time frame: end of study
comparison of UTI occurrence
Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
Time frame: end of study
recurrence of UTI and lab results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
- Derived from this study: PubMed 37947276Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
- Derived from this study: PubMed 37068952Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
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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.
Lynn Stothers, MD principal investigator
Bladder Care Centre, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cranberry juice in people with Urinary Tract Infection, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in Canada.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs (time frame: end of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100061, which also lists 2 linked publications.
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 12 Mar 2013.