BacteriuriaPhase 1NCT01033383

Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

A Phase 1 study testing Cranberry Capsule in people with Bacteriuria, run by Yale University at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. Read more about this study

Who is it for?: Ages 65 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Bacteriuria
What is being tested?: Cranberry Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 14 sitesUnited States
Study dates: Dec 2009to Dec 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
Women only
Healthy volunteers accepted
Older adult

Who may be able to join

Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year.

Who cannot join

residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);
residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
residents with end stage renal disease on dialysis (they do not regularly produce urine);
residents unable to produce a baseline clean catch urine specimen for collection;
residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Northbridge Health Care Center
Bridgeport, Connecticut, 06606
Sheriden Woods Health Care Center
Bristol, Connecticut, 06010
The Carolton Chronic and Convalescent Hospital
Fairfield, Connecticut, 06824
Glastonbury Health Care Center
Glastonbury, Connecticut, 06033
Middlesex Health Care Center
Middletown, Connecticut, 06457
Wadsworth Glen Health Care and Rehabilitation Center
Middletown, Connecticut, 06457
Beacon Brook Health Care Center
Naugatuck, Connecticut, 06770
Laurel Ridge Health Care Center
Ridgefield, Connecticut, 06877
Shady Knoll Health Center
Seymour, Connecticut, 06483
Litchfield Woods Health Care Center
Torrington, Connecticut, 06790
Maefair Health Care Center
Trumbull, Connecticut, 06111
Masonicare Health Center
Wallingford, Connecticut, 06492
Abbott Terracee Health Center
Waterbury, Connecticut, 06702
Saint Mary Home
West Hartford, Connecticut, 06117

Other trials in United States

About this study

Official title: Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

Read the detailed description

Each subject was enrolled after providing a baseline urine specimen. Cranberry/placebo capsules were consumed for 30 days. Urine specimens were obtained weekly for 4 weeks.

Conditions: Bacteriuria
Being tested: Placebo, Cranberry Capsule
Medical subject headings: Bacteriuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDietary supplement
36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).
Cranberry CapsuleDietary supplement
Also called Ellura
36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).

Study groups in NCT01033383
Study group	Role	What they receive
3 placebo capsules	Placebo comparator	3 placebo capsules qd Receives: Dietary Supplement: Placebo
1 cranberry capsule & 2 placebo capsules	Experimental	1 active cranberry capsule and 2 placebo capsules qd Receives: Dietary Supplement: Placebo; Dietary Supplement: Cranberry Capsule
2 cranberry capsules & 1 placebo capsule	Experimental	2 active cranberry capsules and 1 placebo capsules qd Receives: Dietary Supplement: Placebo; Dietary Supplement: Cranberry Capsule
3 cranberry capsules	Experimental	3 active cranberry capsules qd Receives: Dietary Supplement: Cranberry Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

E.Coli Bacteriuria Plus Pyuria
The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.
Measured: One month

Secondary outcomes (2)

Other Bacteriuria Plus Pyuria
The number of urine cultures and urinalyses (obtained weekly) found with other bacteriuria plus any white blood cells (WBCs) >100,000 colony that include: Proteus, Klebsiella, Enterococcus, beta-hemolytic Streptococci, viridans Streptococci, and organella morganii, Citrobacter freundii, and coagulase-negative Staphylococcus.
Measured: one month
Not Growth
The number of not growth, these include no growth, growth <100,000 CFU/ml, growth >100,000 CFU/ml but no WBCs, and mixed flora.
Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Dec 2010

First posted16 Dec 2009 (estimated)
Study startDec 2009
Primary completionOct 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for BacteriuriaStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01033383
Sponsor's protocol ID: 0908005581
Other IDs: K23AG028691-01A2, UL1RR024139, KL2RR024138
Status last verified: Jul 2013
First submitted: 15 Dec 2009
Last updated: 15 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bianco L, Perrelli E, Towle V, Van Ness PH, Juthani-Mehta M. Pilot randomized controlled dosing study of cranberry capsules for reduction of bacteriuria plus pyuria in female nursing home residents. J Am Geriatr Soc. 2012 Jun;60(6):1180-1. doi: 10.1111/j.1532-5415.2012.03976.x. No abstract available.
PubMed 22690994
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 37947276
Williams 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bacteriuria trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
ClinicalTrials.gov ID: NCT01033383
Acronym / sponsor ID: 0908005581
Conditions: Bacteriuria
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), National Center for Research Resources (NCRR)
Study start: Dec 2009
Primary completion: Oct 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 16 Dec 2009 (estimated)
Results: Posted 15 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Each subject was enrolled after providing a baseline urine specimen. Cranberry/placebo capsules were consumed for 30 days. Urine specimens were obtained weekly for 4 weeks.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
3 placebo capsules	Placebo comparator	Dietary Supplement: Placebo3 placebo capsules qd
1 cranberry capsule & 2 placebo capsules	Experimental	Dietary Supplement: Placebo, Dietary Supplement: Cranberry Capsule1 active cranberry capsule and 2 placebo capsules qd
2 cranberry capsules & 1 placebo capsule	Experimental	Dietary Supplement: Placebo, Dietary Supplement: Cranberry Capsule2 active cranberry capsules and 1 placebo capsules qd
3 cranberry capsules	Experimental	Dietary Supplement: Cranberry Capsule3 active cranberry capsules qd

Who may qualify

Ages: 65 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year.

Key exclusion criteria (6 listed)

residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);
residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
residents with end stage renal disease on dialysis (they do not regularly produce urine);
residents unable to produce a baseline clean catch urine specimen for collection;
residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;

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
Placebo36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).	Dietary supplement	1 cranberry capsule & 2 placebo capsules, 2 cranberry capsules & 1 placebo capsule, 3 placebo capsules
Cranberry CapsuleAlso: Ellura36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).	Dietary supplement	1 cranberry capsule & 2 placebo capsules, 2 cranberry capsules & 1 placebo capsule, 3 cranberry capsules

Primary outcome

E.Coli Bacteriuria Plus Pyuria
Time frame: One month
The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.

2 secondary outcomes

Other Bacteriuria Plus Pyuria
Time frame: one month
Not Growth
Time frame: one month

Results and safety

Results posted to the registry on 15 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3 Placebo Capsules	20	20
1 Cranberry Capsule & 2 Placebo Capsules	20	20
2 Cranberry Capsules & 1 Placebo Capsule	20	20
3 Cranberry Capsules	20	20

Primary outcome: E.Coli Bacteriuria Plus Pyuria

Time frame: One month. Number. Unit: urine cultures and urinalyses

Measure	3 Placebo Capsules n = 20	1 Cranberry Capsule & 2 Placebo Capsules n = 20	2 Cranberry Capsules & 1 Placebo Capsule n = 20	3 Cranberry Capsules n = 20
Value	33	29	23	25

Population analysed: The analysis population were those with completed labs data.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3 Placebo Capsules	0 of 20 (0%)	0 of 20 (0%)	Not reported
1 Cranberry Capsule & 2 Placebo Capsules	0 of 20 (0%)	0 of 20 (0%)	Not reported
2 Cranberry Capsules & 1 Placebo Capsule	0 of 20 (0%)	0 of 20 (0%)	Not reported
3 Cranberry Capsules	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): Of 320 urine specimens that should have been collected by nursing staff, 302 (94%) urine cultures and 294 (92%) urinalyses were obtained.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22690994Bianco L, Perrelli E, Towle V, Van Ness PH, Juthani-Mehta M. Pilot randomized controlled dosing study of cranberry capsules for reduction of bacteriuria plus pyuria in female nursing home residents. J Am Geriatr Soc. 2012 Jun;60(6):1180-1. doi: 10.1111/j.1532-5415.2012.03976.x. No abstract available.
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.

Related trials for Bacteriuria

Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
Not yet recruitingObservational study
Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University
Pre-Eclampsia, Asymptomatic Bacteriuria
Not yet recruiting
Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Disease
RecruitingPhase 1
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
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RecruitingObservational study
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter

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.

Manisha Juthani-Mehta, MD principal investigator

Yale University

14 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 Capsule in people with Bacteriuria, run by Yale University at 14 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 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 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 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?

Yes. Results are posted in the registry (first posted 15 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

E.Coli Bacteriuria Plus Pyuria (time frame: One month). 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 NCT01033383, 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 15 Aug 2013.