Urinary Tract InfectionsPhase 2NCT00128128
Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections
A Phase 2 study testing Cranberry juice cocktail in people with Urinary Tract Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial summary
This study will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cranberry juice cocktail
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Jun 2009
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- At least one UTI within 12 months prior to study entry
- Premenopausal
- Agree to avoid all foods that contain plants from the genus Vaccinium (related to cranberries) for the duration of the study
Who cannot join
- Anatomic abnormalities of the urinary tract
- History of kidney stones
- Bacteria in the urine (bacteriuria)
- Use of prophylactic antibiotics within 7 days prior to study entry
- Use of investigational drugs within 30 days prior to study entry
- Current use of warfarin
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- Diabetes
- Cancer. Participants with skin cancer are not excluded.
- Allergy or intolerance of cranberry products
- Symptomatic vaginitis
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital
New Haven, Connecticut, 06520
University of Washington
Seattle, Washington, 02195
About this study
Official title: Cranberry and Prevention of UTI A Comprehensive Approach
This study will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year.
Read the detailed description
UTIs are a common problem among young women, resulting in considerable morbidity and health care costs. Increasing resistance to antibiotics is making treatment of these infections even more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are needed. One approach that appears to be effective is the use of cranberry products. However, data on the safety and effectiveness of cranberry products are limited. This study will determine whether cranberry juice can reduce UTIs in women.
Participants will be randomly assigned to receive either cranberry juice or a placebo drink daily for 6 months. Study visits will occur every month for the 6-month treatment phase of the study. At study entry and at each study visit, urine collection will occur and vaginal swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4 visits. Participants will be asked about medication usage, any side effects they may be experiencing, and diet at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.
- Conditions
- Urinary Tract Infections
- Being tested
- Cranberry juice cocktail
- Keywords
- Vaccinium macrocarpon, Cranberry, Complementary Therapies
- 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 juice cocktailDrug
Also called CJC, cranberry
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Cranberry Juice Cocktail- 4 ounces Receives: Drug: Cranberry juice cocktail |
| Arm 2 | Active comparator | Cranberry Juice Cocktail-8 ounces Receives: Drug: Cranberry juice cocktail |
| Arm 3 | Placebo comparator | Placebo- 4 ounces Receives: Drug: Cranberry juice cocktail |
| Arm 4 | Placebo comparator | Placebo- 8 ounces Receives: Drug: Cranberry juice cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of UTIs
Measured: 6 months
Secondary outcomes (2)
Compliance
Measured: 6 months
vaginal and rectal colonization with E. coli
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 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
- Kalpana Gupta, MD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128128
- Sponsor's protocol ID
- R01AT002105-01
- Status last verified
- May 2015
- First submitted
- 5 Aug 2005
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stapleton AE, Dziura J, Hooton TM, Cox ME, Yarova-Yarovaya Y, Chen S, Gupta K. Recurrent urinary tract infection and urinary Escherichia coli in women ingesting cranberry juice daily: a randomized controlled trial. Mayo Clin Proc. 2012 Feb;87(2):143-50. doi: 10.1016/j.mayocp.2011.10.006.
PubMed 22305026Williams 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 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry and Prevention of UTI A Comprehensive Approach
- ClinicalTrials.gov ID
- NCT00128128
- Acronym / sponsor ID
- R01AT002105-01
- Conditions
- Urinary Tract Infections
- Keywords
- Vaccinium macrocarpon, Cranberry, Complementary Therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Aug 2005 (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 will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year.
Detailed description
UTIs are a common problem among young women, resulting in considerable morbidity and health care costs. Increasing resistance to antibiotics is making treatment of these infections even more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are needed. One approach that appears to be effective is the use of cranberry products. However, data on the safety and effectiveness of cranberry products are limited. This study will determine whether cranberry juice can reduce UTIs in women.
Participants will be randomly assigned to receive either cranberry juice or a placebo drink daily for 6 months. Study visits will occur every month for the 6-month treatment phase of the study. At study entry and at each study visit, urine collection will occur and vaginal swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4 visits. Participants will be asked about medication usage, any side effects they may be experiencing, and diet at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Cranberry juice cocktailCranberry Juice Cocktail- 4 ounces |
| Arm 2 | Active comparator | Drug: Cranberry juice cocktailCranberry Juice Cocktail-8 ounces |
| Arm 3 | Placebo comparator | Drug: Cranberry juice cocktailPlacebo- 4 ounces |
| Arm 4 | Placebo comparator | Drug: Cranberry juice cocktailPlacebo- 8 ounces |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least one UTI within 12 months prior to study entry
- Premenopausal
- Agree to avoid all foods that contain plants from the genus Vaccinium (related to cranberries) for the duration of the study
Key exclusion criteria (11 listed)
- Anatomic abnormalities of the urinary tract
- History of kidney stones
- Bacteria in the urine (bacteriuria)
- Use of prophylactic antibiotics within 7 days prior to study entry
- Use of investigational drugs within 30 days prior to study entry
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 cocktailAlso: CJC, cranberryParticipants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months. | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Rate of UTIs
Time frame: 6 months
2 secondary outcomes
Compliance
Time frame: 6 months
vaginal and rectal colonization with E. coli
Time frame: 6 months
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 4 Jun 2015.
- Results publication: PubMed 22305026Stapleton AE, Dziura J, Hooton TM, Cox ME, Yarova-Yarovaya Y, Chen S, Gupta K. Recurrent urinary tract infection and urinary Escherichia coli in women ingesting cranberry juice daily: a randomized controlled trial. Mayo Clin Proc. 2012 Feb;87(2):143-50. doi: 10.1016/j.mayocp.2011.10.006.
- 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.
Kalpana Gupta, MD, MPH principal investigator
Boston University
2 sites 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 cocktail in people with Urinary Tract Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites 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 3 inclusion and 11 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 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
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?
Rate of UTIs (time frame: 6 months). 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 NCT00128128, which also lists 3 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 4 Jun 2015.