NCT00093054

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2004

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

September 30, 2004

Last Update Submit

April 14, 2015

Conditions

Urinary Tract Infections

Keywords

Vaccinium macrocarpon

Outcome Measures

Primary Outcomes (1)

  • Culture

    per visit

Study Arms (2)

1

ACTIVE COMPARATOR

Cranberry juice

Drug: Cranberry juice

2

PLACEBO COMPARATOR

Placebo juice

Dietary Supplement: Placebo cranberry juice

Interventions

Cranberry juiceDRUG

TID dosage for UTI treatment

1
Placebo cranberry juiceDIETARY_SUPPLEMENT

TID placebo dosage to match active comparator

2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Culture-confirmed urinary tract infection at study start

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Cibele T. Barbosa-Cesnik

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2004

First Posted

October 1, 2004

Study Start

November 1, 2004

Primary Completion

March 1, 2008

Study Completion

December 1, 2009

Last Updated

May 5, 2015

Record last verified: 2015-04

Locations

US(1)