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Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cranberry juice cocktail
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring Vaccinium macrocarpon, Cranberry, Complementary Therapies

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven Hospital
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Cranberry Juice Cocktail- 4 ounces

Cranberry Juice Cocktail-8 ounces

Placebo- 4 ounces

Placebo- 8 ounces

Outcomes

Primary Outcome Measures

Rate of UTIs

Secondary Outcome Measures

Compliance
vaginal and rectal colonization with E. coli

Full Information

First Posted
August 5, 2005
Last Updated
May 14, 2015
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00128128
Brief Title
Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections
Official Title
Cranberry and Prevention of UTI A Comprehensive Approach
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Vaccinium macrocarpon, Cranberry, Complementary Therapies

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Cranberry Juice Cocktail- 4 ounces
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Cranberry Juice Cocktail-8 ounces
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo- 4 ounces
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
Placebo- 8 ounces
Intervention Type
Drug
Intervention Name(s)
Cranberry juice cocktail
Other Intervention Name(s)
CJC, cranberry
Intervention Description
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Primary Outcome Measure Information:
Title
Rate of UTIs
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Compliance
Time Frame
6 months
Title
vaginal and rectal colonization with E. coli
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalpana Gupta, MD, MPH
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
02195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22305026
Citation
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. doi: 10.1016/j.mayocp.2011.10.006.
Results Reference
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Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

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