Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

Urinary Tract Infections Clinical Trial

Official title:

Cranberry and Prevention of UTI A Comprehensive Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128128
• Other study ID #: R01AT002105-01
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2005
• Last updated: May 14, 2015
• Start date: August 2005
• Est. completion date: June 2009

Study information

• Verified date: May 2015
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Diabetes

• Cancer. Participants with skin cancer are not excluded.

• Allergy or intolerance of cranberry products

• Symptomatic vaginitis

• Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Drug:
• Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of UTIs		6 months	No
Secondary	Compliance		6 months	No
Secondary	vaginal and rectal colonization with E. coli		6 months	No