Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

NCT ID: NCT00128128

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Cranberry Juice Cocktail- 4 ounces

Group Type ACTIVE_COMPARATOR

Cranberry juice cocktail

Intervention Type DRUG

Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.

Arm 2

Cranberry Juice Cocktail-8 ounces

Group Type ACTIVE_COMPARATOR

Cranberry juice cocktail

Intervention Type DRUG

Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.

Arm 3

Placebo- 4 ounces

Group Type PLACEBO_COMPARATOR

Cranberry juice cocktail

Intervention Type DRUG

Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.

Arm 4

Placebo- 8 ounces

Group Type PLACEBO_COMPARATOR

Cranberry juice cocktail

Intervention Type DRUG

Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.

Interventions

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Cranberry juice cocktail

Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.

Intervention Type DRUG

Other Intervention Names

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CJC cranberry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kalpana Gupta, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22305026 (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

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R01AT002105-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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