NCT00128128

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

August 1, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 4, 2015

Status Verified

May 1, 2015

Enrollment Period

3.3 years

First QC Date

August 5, 2005

Last Update Submit

May 14, 2015

Conditions

Urinary Tract Infections

Keywords

Vaccinium macrocarponCranberryComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Rate of UTIs

    6 months

Secondary Outcomes (2)

  • Compliance

    6 months

  • vaginal and rectal colonization with E. coli

    6 months

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Cranberry Juice Cocktail- 4 ounces

Drug: Cranberry juice cocktail

Arm 2

ACTIVE COMPARATOR

Cranberry Juice Cocktail-8 ounces

Drug: Cranberry juice cocktail

Arm 3

PLACEBO COMPARATOR

Placebo- 4 ounces

Drug: Cranberry juice cocktail

Arm 4

PLACEBO COMPARATOR

Placebo- 8 ounces

Drug: Cranberry juice cocktail

Interventions

Cranberry juice cocktailDRUG

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

Also known as: CJC, cranberry
Arm 1Arm 2Arm 3Arm 4

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

University of Washington

Seattle, Washington, 02195, United States

Location

Related Publications (3)

  • 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.

    PMID: 22305026RESULT

  • 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.

    PMID: 37947276DERIVED

  • 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.

    PMID: 37068952DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kalpana Gupta, MD, MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 9, 2005

Study Start

August 1, 2005

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

June 4, 2015

Record last verified: 2015-05

Locations

US(2)