Urinary Tract InfectionPhase 1NCT00093938
Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
A Phase 1 study testing Cranberry juice in people with Urinary Tract Infection and Bacteriuria, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial summary
The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection, Bacteriuria
- What is being tested?
- Cranberry juice
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2004to not given
- Phase
- Phase 1
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intrauterine pregnancy
- Mother and fetus in good health
- Mother pregnant for 16 weeks or less
Who cannot join
- Suspected nonviable or ectopic pregnancy
- Mother plans to terminate pregnancy
- Antimicrobial therapy, for reasons other than urinary tract infections, within 2 weeks prior to study start
- Significant underlying medical complications that may interfere with the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
Long Beach, California, 90806
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Official title: Cranberry for Prevention of Bacteriuria in Pregnancy
The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).
Read the detailed description
Asymptomatic bacteriuria (ASB) infection, a condition in which a large number of bacteria are present in the urine, often precedes the development of symptomatic UTIs. UTIs are common among women and may create complications during pregnancy. By incorporating cranberry juice into their diets, pregnant women may be able to lower their risk for UTIs caused by ASB, and cranberry juice may also prevent preterm labor and birth. This study will determine the cranberry juice-containing regimen that will work best for preventing ASB in pregnant women.
For the duration of their pregnancy, participants in this study will be randomly assigned to one of three treatment arms: cranberry juice once a day, cranberry juice three times a day, or a placebo beverage three times a day. The level of bacteria in their urine will be measured at monthly study visits. Women who test positive for a UTI will receive oral antibiotic therapy. All women will be monitored throughout their pregnancies for UTIs and other related complications.
- Conditions
- Urinary Tract Infection, Bacteriuria
- Being tested
- Cranberry juice
- Keywords
- Vaccinium macrocarpon, Asymptomatic Bacteriuria
- Medical subject headings
- Urinary Tract Infections, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry juiceDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of asymptomatic bacteriuria
Secondary outcomes (3)
Number of cases of symptomatic urinary tract infection
Compliance with recommended therapy
Number of preterm deliveries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Deborah A. Wing, MD, Principal investigator, University of California, Irvine Medical Center/Long Beach Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093938
- Sponsor's protocol ID
- DK068527-01 (completed)
- Status last verified
- Jan 2010
- First submitted
- 7 Oct 2004
- Last updated
- 14 Jan 2010
- Results posted
- No
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 37068952Wing DA, Rumney PJ, Leu SY, Zaldivar F. Comparison of urinary cytokines after ingestion of cranberry juice cocktail in pregnant subjects: a pilot study. Am J Perinatol. 2010 Feb;27(2):137-42. doi: 10.1055/s-0029-1224867. Epub 2009 Jun 26.
PubMed 19562652Wing DA, Rumney PJ, Preslicka CW, Chung JH. Daily cranberry juice for the prevention of asymptomatic bacteriuria in pregnancy: a randomized, controlled pilot study. J Urol. 2008 Oct;180(4):1367-72. doi: 10.1016/j.juro.2008.06.016. Epub 2008 Aug 15.
PubMed 18707726
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry for Prevention of Bacteriuria in Pregnancy
- ClinicalTrials.gov ID
- NCT00093938
- Acronym / sponsor ID
- DK068527-01 (completed)
- Conditions
- Urinary Tract Infection, Bacteriuria
- Keywords
- Vaccinium macrocarpon, Asymptomatic Bacteriuria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Dec 2004
- First posted
- 8 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 the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).
Detailed description
Asymptomatic bacteriuria (ASB) infection, a condition in which a large number of bacteria are present in the urine, often precedes the development of symptomatic UTIs. UTIs are common among women and may create complications during pregnancy. By incorporating cranberry juice into their diets, pregnant women may be able to lower their risk for UTIs caused by ASB, and cranberry juice may also prevent preterm labor and birth. This study will determine the cranberry juice-containing regimen that will work best for preventing ASB in pregnant women.
For the duration of their pregnancy, participants in this study will be randomly assigned to one of three treatment arms: cranberry juice once a day, cranberry juice three times a day, or a placebo beverage three times a day. The level of bacteria in their urine will be measured at monthly study visits. Women who test positive for a UTI will receive oral antibiotic therapy. All women will be monitored throughout their pregnancies for UTIs and other related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intrauterine pregnancy
- Mother and fetus in good health
- Mother pregnant for 16 weeks or less
Key exclusion criteria (4 listed)
- Suspected nonviable or ectopic pregnancy
- Mother plans to terminate pregnancy
- Antimicrobial therapy, for reasons other than urinary tract infections, within 2 weeks prior to study start
- Significant underlying medical complications that may interfere with the study
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 | Drug | – |
Primary outcome
Number of cases of asymptomatic bacteriuria
3 secondary outcomes
Number of cases of symptomatic urinary tract infection
Compliance with recommended therapy
Number of preterm deliveries
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 14 Jan 2010.
- 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.
- Derived from this study: PubMed 19562652Wing DA, Rumney PJ, Leu SY, Zaldivar F. Comparison of urinary cytokines after ingestion of cranberry juice cocktail in pregnant subjects: a pilot study. Am J Perinatol. 2010 Feb;27(2):137-42. doi: 10.1055/s-0029-1224867. Epub 2009 Jun 26.
- Derived from this study: PubMed 18707726Wing DA, Rumney PJ, Preslicka CW, Chung JH. Daily cranberry juice for the prevention of asymptomatic bacteriuria in pregnancy: a randomized, controlled pilot study. J Urol. 2008 Oct;180(4):1367-72. doi: 10.1016/j.juro.2008.06.016. Epub 2008 Aug 15.
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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.
Deborah A. Wing, MD principal investigator
University of California, Irvine Medical Center/Long Beach Memorial Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cranberry juice in people with Urinary Tract Infection and Bacteriuria, 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 4 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 14 Jan 2010. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of cases of asymptomatic bacteriuria. 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 NCT00093938, which also lists 4 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 14 Jan 2010.