Urinary Tract InfectionPhase 4NCT01881165
Cranberry on Urinary Tract Infections
A Phase 4 study testing Cranberry in people with Urinary Tract Infection, run by University of British Columbia at 1 site in Canada.
Trial summary
This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women who consume it. About 150 adult women will participate in this study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or a placebo for 12 months. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Cranberry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Mar 2016
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding
- Are sexually active
Who cannot join
- Current UTI
- Pregnant or breastfeeding or planning a pregnancy in the next 12 months
- A known allergy or intolerance to cranberry-containing products
- A history of renal stones and/or renal transplantation
- Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
- Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
Show all 10Show fewer
- Intermittent or indwelling catheterization
- Any anatomic abnormalities of the urinary tract
- The use of any antibiotics within 2 weeks before study entry
- The use of any natural health products, including herbs, homeopathic products, or other forms of cranberry supplements within 2 weeks before study entry
Trial locations and contacts
1 site in 1 country.
Canada1 site
The University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate in Preventing Recurrent Urinary Tract Infections in Adult Women
This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women who consume it. About 150 adult women will participate in this study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or a placebo for 12 months. We expect cranberry supplement to have better results than the placebo. Subjects will not know which supplement they are taking. The primary outcome is the number of UTIs over 12 months.
Read the detailed description
Participants will attend their first study visit at a clinic at UBC. They will be randomized to the cranberry capsule or placebo. Participants will be instructed to consume the assigned supplement for the next 12 months. A calendar will be provided to record compliance and recurrent UTI. Participants will also record any side effects. They will be phoned each month to encourage participation and adherence. At 8 weeks and 6 months, they will be asked to return to the clinic to complete a midline questionnaire which will ask about any recurrent UTIs experienced. More supplements will be provided at their 6-month visit. At 12 months, participants will return to the clinic to complete an endline questionnaire. They will return any leftover supplements, calendar and side effect diary. If participants withdraw from the study, they will still be encouraged to return at 12 months to complete the survey to allow for intent-to-treat analysis.
- Conditions
- Urinary Tract Infection
- Being tested
- Cranberry, Placebo
- 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.
CranberryDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cranberry | Experimental | Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate). Receives: Drug: Cranberry |
| Placebo | Placebo comparator | A capsule containing control formulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of urinary tract infections
The number of symptomatic UTIs over 12 months (defined by self-report as having one or more of the following symptoms: dysuria, frequency, urgency, hematuria, supra-pubic pressure or fever), the proportion of participants with at least 1 symptomatic UTI, the median time to the first UTI
Measured: 12 months
Secondary outcomes (1)
Side effects
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Sponsor declined funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Green, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881165
- Sponsor's protocol ID
- H13-01491
- Status last verified
- Dec 2014
- First submitted
- 17 Jun 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate in Preventing Recurrent Urinary Tract Infections in Adult Women
- ClinicalTrials.gov ID
- NCT01881165
- Acronym / sponsor ID
- H13-01491
- Conditions
- Urinary Tract Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor declined funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 19 Jun 2013 (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.
This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women who consume it. About 150 adult women will participate in this study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or a placebo for 12 months. We expect cranberry supplement to have better results than the placebo. Subjects will not know which supplement they are taking. The primary outcome is the number of UTIs over 12 months.
Detailed description
Participants will attend their first study visit at a clinic at UBC. They will be randomized to the cranberry capsule or placebo. Participants will be instructed to consume the assigned supplement for the next 12 months. A calendar will be provided to record compliance and recurrent UTI. Participants will also record any side effects. They will be phoned each month to encourage participation and adherence. At 8 weeks and 6 months, they will be asked to return to the clinic to complete a midline questionnaire which will ask about any recurrent UTIs experienced. More supplements will be provided at their 6-month visit. At 12 months, participants will return to the clinic to complete an endline questionnaire. They will return any leftover supplements, calendar and side effect diary. If participants withdraw from the study, they will still be encouraged to return at 12 months to complete the survey to allow for intent-to-treat analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry | Experimental | Drug: CranberryEach capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate). |
| Placebo | Placebo comparator | Drug: PlaceboA capsule containing control formulation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding
- Are sexually active
Key exclusion criteria (10 listed)
- Current UTI
- Pregnant or breastfeeding or planning a pregnancy in the next 12 months
- A known allergy or intolerance to cranberry-containing products
- A history of renal stones and/or renal transplantation
- Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
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 | Drug | Cranberry |
| Placebo | Drug | Placebo |
Primary outcome
Number of urinary tract infections
Time frame: 12 months
The number of symptomatic UTIs over 12 months (defined by self-report as having one or more of the following symptoms: dysuria, frequency, urgency, hematuria, supra-pubic pressure or fever), the proportion of participants with at least 1 symptomatic UTI, the median time to the first UTI
1 secondary outcome
Side effects
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
Tim Green, PhD principal investigator
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 4 study testing Cranberry in people with Urinary Tract Infection, run by University of British Columbia 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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 16 Dec 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of urinary tract infections (time frame: 12 months). 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 16 Dec 2014.