Cranberry Juice for Treatment of Urinary Tract Infections

NCT ID: NCT00093054

Last Updated: 2015-05-05

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/PHASE3

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.

Detailed Description

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Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Cranberry juice

Group Type ACTIVE_COMPARATOR

Cranberry juice

Intervention Type DRUG

TID dosage for UTI treatment

2

Placebo juice

Group Type PLACEBO_COMPARATOR

Placebo cranberry juice

Intervention Type DIETARY_SUPPLEMENT

TID placebo dosage to match active comparator

Interventions

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Cranberry juice

TID dosage for UTI treatment

Intervention Type DRUG

Placebo cranberry juice

TID placebo dosage to match active comparator

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Culture-confirmed urinary tract infection at study start

Exclusion Criteria

* Other chronic disease
* Antibiotics within 48 hours prior to study start
* Hospitalization for any reason within 2 weeks prior to study start
* Stones in urinary tract
* Plans to leave Ann Arbor within 6 months after study start
* Allergy to cranberry or cranberry compounds
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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Cibele T. Barbosa-Cesnik

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R01AT002086

Identifier Type: NIH

Identifier Source: org_study_id

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