Urinary Tract InfectionsNCT00087828
Identification of the Cranberry Juice Compounds That Prevent Urinary Tract Infections
A study testing Cranberry juice cocktail 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 identify the substances in cranberry juice that make it effective in reducing urinary tract infections (UTIs) in women. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cranberry juice cocktail
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Jun 2005
- Phase
- Interventional
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good overall health
Who cannot join
- History of urinary tract infections
- Use of cranberry products or antibiotics within 1 week of study start
- Current use of any other medication
- Hypertension
- Diabetes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept Medicinal Chemistry & Pharmacognosy, COP, UIC
Chicago, Illinois, 60612
About this study
Official title: Cranberry Juice Metabolites in Urine
The purpose of this study is to identify the substances in cranberry juice that make it effective in reducing urinary tract infections (UTIs) in women.
Read the detailed description
Urinary tract infections (UTIs) are a significant health issue, with one fourth of all women experiencing symptoms during their lifetimes. Cranberry juice has been shown to reduce the incidence of UTIs by preventing bacteria from adhering to the bladder. However, the compounds that direct this activity have not been identified. This study will identify and examine UTI-reducing compounds in cranberry juice.
Participants in this study will drink a specified amount of water following an overnight fast. Their urine will be collected 1 to 3 hours after the water is consumed. Several days later, the women will be provided with cranberry juice to replace the water in the regimen. Urine samples will be analyzed for compounds that have antibacterial or antiadhesion activity against the bacteria that cause UTIs.
- Conditions
- Urinary Tract Infections
- Being tested
- Cranberry juice cocktail
- 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 juice cocktailDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study startNov 2000
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan Turner, MD, Principal investigator, UIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087828
- Sponsor's protocol ID
- F31 AT000623-1
- Other IDs
- F31AT000623
- Status last verified
- Aug 2006
- First submitted
- 14 Jul 2004
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Ahuja S, Kaack B, Roberts J. Loss of fimbrial adhesion with the addition of Vaccinum macrocarpon to the growth medium of P-fimbriated Escherichia coli. J Urol. 1998 Feb;159(2):559-62. doi: 10.1016/s0022-5347(01)63983-1.
PubMed 9649291Avorn J, Monane M, Gurwitz JH, Glynn RJ, Choodnovskiy I, Lipsitz LA. Reduction of bacteriuria and pyuria after ingestion of cranberry juice. JAMA. 1994 Mar 9;271(10):751-4. doi: 10.1001/jama.1994.03510340041031.
PubMed 8093138Foo LY, Lu Y, Howell AB, Vorsa N. A-Type proanthocyanidin trimers from cranberry that inhibit adherence of uropathogenic P-fimbriated Escherichia coli. J Nat Prod. 2000 Sep;63(9):1225-8. doi: 10.1021/np000128u.
PubMed 11000024Foo LY, Lu Y, Howell AB, Vorsa N. The structure of cranberry proanthocyanidins which inhibit adherence of uropathogenic P-fimbriated Escherichia coli in vitro. Phytochemistry. 2000 May;54(2):173-81. doi: 10.1016/s0031-9422(99)00573-7.
PubMed 10872208Schmidt DR, Sobota AE. An examination of the anti-adherence activity of cranberry juice on urinary and nonurinary bacterial isolates. Microbios. 1988;55(224-225):173-81.
PubMed 3063927
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry Juice Metabolites in Urine
- ClinicalTrials.gov ID
- NCT00087828
- Acronym / sponsor ID
- F31 AT000623-1
- Conditions
- Urinary Tract Infections
- Keywords
- Vaccinium macrocarpon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Nov 2000
- Study completion
- Jun 2005
- First posted
- 16 Jul 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 identify the substances in cranberry juice that make it effective in reducing urinary tract infections (UTIs) in women.
Detailed description
Urinary tract infections (UTIs) are a significant health issue, with one fourth of all women experiencing symptoms during their lifetimes. Cranberry juice has been shown to reduce the incidence of UTIs by preventing bacteria from adhering to the bladder. However, the compounds that direct this activity have not been identified. This study will identify and examine UTI-reducing compounds in cranberry juice.
Participants in this study will drink a specified amount of water following an overnight fast. Their urine will be collected 1 to 3 hours after the water is consumed. Several days later, the women will be provided with cranberry juice to replace the water in the regimen. Urine samples will be analyzed for compounds that have antibacterial or antiadhesion activity against the bacteria that cause UTIs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Good overall health
Key exclusion criteria (6 listed)
- History of urinary tract infections
- Use of cranberry products or antibiotics within 1 week of study start
- Current use of any other medication
- Hypertension
- Diabetes
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 cocktail | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
- Background: PubMed 9649291Ahuja S, Kaack B, Roberts J. Loss of fimbrial adhesion with the addition of Vaccinum macrocarpon to the growth medium of P-fimbriated Escherichia coli. J Urol. 1998 Feb;159(2):559-62. doi: 10.1016/s0022-5347(01)63983-1.
- Background: PubMed 8093138Avorn J, Monane M, Gurwitz JH, Glynn RJ, Choodnovskiy I, Lipsitz LA. Reduction of bacteriuria and pyuria after ingestion of cranberry juice. JAMA. 1994 Mar 9;271(10):751-4. doi: 10.1001/jama.1994.03510340041031.
- Background: PubMed 11000024Foo LY, Lu Y, Howell AB, Vorsa N. A-Type proanthocyanidin trimers from cranberry that inhibit adherence of uropathogenic P-fimbriated Escherichia coli. J Nat Prod. 2000 Sep;63(9):1225-8. doi: 10.1021/np000128u.
- Background: PubMed 10872208Foo LY, Lu Y, Howell AB, Vorsa N. The structure of cranberry proanthocyanidins which inhibit adherence of uropathogenic P-fimbriated Escherichia coli in vitro. Phytochemistry. 2000 May;54(2):173-81. doi: 10.1016/s0031-9422(99)00573-7.
- Background: PubMed 3063927Schmidt DR, Sobota AE. An examination of the anti-adherence activity of cranberry juice on urinary and nonurinary bacterial isolates. Microbios. 1988;55(224-225):173-81.
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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.
Susan Turner, MD principal investigator
UIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry juice cocktail 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 6 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 18 Aug 2006. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00087828, which also lists 5 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 18 Aug 2006.