Cranberry for UTI Prevention in Residents of Long Term Care Facilities

NCT ID: NCT00596635

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-08-31

Brief Summary

Urinary tract infections (UTIs) affect over 7 million men and women per year and cost the health care industry over 1 billion dollars annually. The incidence of UTI increases markedly in elderly institutionalized persons and leads to excessive antimicrobial usage, emergency room visits, hospitalization, sepsis, and death. The use of antimicrobials to prevent UTI in elderly nursing home patients is not recommended and is fraught with problems such as adverse reactions, drug interactions, and the development of drug-resistant organisms. There is no accepted method of preventing UTI in residents of nursing homes, a vulnerable and understudied population with significant morbidity from UTI.

The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for future larger studies.

Detailed Description

Cranberry products represent a novel, non-antimicrobial method for prevention of UTI. There is evidence for a plausible mechanism and efficacy for UTI prevention in healthy premenopausal women. Limited clinical studies of cranberry products in elderly men and women have demonstrated reductions in bacteriuria but have not been of adequate size or quality to support the use of cranberry in this population or result in changes in patient care. Thus, a properly designed, definitive study demonstrating efficacy of cranberry in preventing UTI in this population is needed. However, before a large-scale, placebo-controlled trial can be justified, the complexities inherent to studying older nursing home residents need to be addressed. These include issues related to collecting uncontaminated urine samples, understanding the microbiology of UTI in this population, and devising an acceptable intervention regimen. The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims listed below is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for a future RO1 level grant application.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

No cranberry capsules administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

One cranberry capsule

1 650mg cranberry capsule daily

Group Type: ACTIVE_COMPARATOR

Once Daily Cranberry Capsule

Intervention Type: DIETARY_SUPPLEMENT

650mg capsule pure cranberry powder

Two cranberry capsules

1 650 mg cranberry capsule twice daily (bid)

Group Type: ACTIVE_COMPARATOR

Twice Daily Cranberry Capsules

Intervention Type: DIETARY_SUPPLEMENT

One 650mg cranberry capsule administered twice per day

Interventions

Once Daily Cranberry Capsule

650mg capsule pure cranberry powder

Intervention Type: DIETARY_SUPPLEMENT

Twice Daily Cranberry Capsules

One 650mg cranberry capsule administered twice per day

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Theralogix: Theracran cranberry supplement, 650mg capsule; Theralogix: Theracran cranberry supplement, 650mg capsule

Eligibility Criteria

Inclusion Criteria

• Greater than 60 years old and a resident of the nursing home or assisted living facility for greater than 30 days duration

Exclusion Criteria

• Having a known major anatomic abnormality of the urinary tract
• Presence of acute UTI symptom
• Intolerance or allergy to cranberry products
• Current use of cranberry for prevention of UTI
• Use of warfarin
• History of kidney stones
• Presence of a chronic indwelling bladder catheter
• Dialysis dependence
• Chronic suppressive antibiotics
• Immunocompromised state due to hematological malignancies, HIV infection, chronic high dose (>10mg daily) prednisone or equivalent steroid use.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manisha Juthani-Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Medicine, Assistant Professor

Locations

Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases

New Haven, Connecticut, United States

Countries

United States

References

Juthani-Mehta M, Perley L, Chen S, Dziura J, Gupta K. Feasibility of cranberry capsule administration and clean-catch urine collection in long-term care residents. J Am Geriatr Soc. 2010 Oct;58(10):2028-30. doi: 10.1111/j.1532-5415.2010.03080.x. No abstract available.

Reference Type: RESULT

PMID: 20929476 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37947276 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37068952 (View on PubMed)

Other Identifiers

DF06-005

Identifier Type: -

Identifier Source: secondary_id

0606001581

Identifier Type: -

Identifier Source: org_study_id