Urinary Tract InfectionsPhase 2/3NCT00093054
Cranberry Juice for Treatment of Urinary Tract Infections
A Phase 2/3 study testing Cranberry juice in people with Urinary Tract Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cranberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2009
- Phase
- Phase 2/3
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Culture-confirmed urinary tract infection at study start
Who cannot join
- Other chronic disease
- Antibiotics within 48 hours prior to study start
- Hospitalization for any reason within 2 weeks prior to study start
- Stones in urinary tract
- Plans to leave Ann Arbor within 6 months after study start
- Allergy to cranberry or cranberry compounds
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cranberry Juice and Urinary Tract Infections
The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.
Read the detailed description
Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.
- Conditions
- Urinary Tract Infections
- Being tested
- Cranberry juice, Placebo cranberry juice
- Keywords
- 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
TID dosage for UTI treatment
Placebo cranberry juiceDietary supplement
TID placebo dosage to match active comparator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cranberry juice Receives: Drug: Cranberry juice |
| 2 | Placebo comparator | Placebo juice Receives: Dietary Supplement: Placebo cranberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture
Measured: per visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2004 (estimated)
- Study startNov 2004
- Primary completionMar 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Cibele T. Barbosa-Cesnik, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093054
- Sponsor's protocol ID
- R01AT002086
- Status last verified
- Apr 2015
- First submitted
- 30 Sep 2004
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry Juice and Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT00093054
- Acronym / sponsor ID
- R01AT002086
- Conditions
- Urinary Tract Infections
- Keywords
- Vaccinium macrocarpon
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Nov 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Oct 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 whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.
Detailed description
Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Cranberry juiceCranberry juice |
| 2 | Placebo comparator | Dietary Supplement: Placebo cranberry juicePlacebo juice |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Culture-confirmed urinary tract infection at study start
Key exclusion criteria (7 listed)
- Other chronic disease
- Antibiotics within 48 hours prior to study start
- Hospitalization for any reason within 2 weeks prior to study start
- Stones in urinary tract
- Plans to leave Ann Arbor within 6 months after study start
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 juiceTID dosage for UTI treatment | Drug | 1 |
| Placebo cranberry juiceTID placebo dosage to match active comparator | Dietary supplement | 2 |
Primary outcome
Culture
Time frame: per visit
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 5 May 2015.
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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.
Cibele T. Barbosa-Cesnik principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cranberry juice in people with Urinary Tract Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 1 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 5 May 2015. 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 United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Culture (time frame: per visit). 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 5 May 2015.