Back to results

Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

Primary Purpose

Urinary Tract Infections, Infection, Urologic Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cranberry juice

placebo beverage

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring Urinary tract infection, Recurrent urinary tract infection, Cranberry, Prevention, E-coli

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Subject has had at least 2 episodes of a UTI treated by a healthcare professional in the last year and at least 1 treated UTI within the last 6 months.
Subject is willing to avoid listed Vaccinium products (including cranberry juice, cranberries, craisins, blueberries, cranberry/blueberry powders, pills, or supplements, probiotics) for 2 weeks prior to enrollment and throughout intervention.
Subject agrees to avoid probiotic dietary supplements for 2 weeks prior to enrollment and throughout intervention.
Subject agrees to limit all probiotic-containing foods/yogurt and yogurt-containing products to no more than an 8 oz serving/d within 2 weeks prior to enrollment and throughout intervention.
Subject is willing to limit all soda, pop or energy drinks (diet or regular sweetened) to < 20 oz/d within 2 weeks prior to and throughout intervention.

Exclusion Criteria:

Subject has an in-dwelling catheter, polycystic disease, interstitial cystitis, previous urological surgery, stones, or anatomical abnormalities of the urinary tract, spinal cord injury, immuno-compromised conditions, severe renal impairment, or multiple sclerosis.
Subject has a history of antibiotic prophylaxis use for UTI. A 2-week washout period prior to enrollment will be allowed.
Subject has a body mass index (BMI) >40.0 kg/m2.
Subjects with diabetes mellitus and HbA1C >8.0% prior to enrollment.
Subject has diabetes mellitus treated with insulin.
Subject has an active infection or sign/symptoms of an infection (i.e., including a UTI).
Subject has used oral anti-coagulants within the last 4 weeks.
Subject has a history or presence of cancer in the prior two years, except for nonmelanoma skin cancer.
Subject is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.

Sites / Locations

Ocean Spray Cranberries Research Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

cranberry juice

Placebo

Arm Description

cranberry juice beverage at a dose of one 8 oz. beverage per day for six months

placebo beverage at a dose of one 8 oz. beverage per day for six months

Outcomes

Primary Outcome Measures

The primary outcome variable will be UTI incidence density, defined as the semi-annualized number of UTIs in each group, adjusted for susceptible time under observation.

Secondary Outcome Measures

Time from randomization to first clinical UTI. Time from randomization to first clinical UTI w/ pyuria. Time from randomization to first clinical UTI w/ microbiological verification. The fraction of subjects w/ one or more episode(s) of clinical UTI.

Full Information

NCT ID

NCT01776021

First Posted

January 23, 2013

Last Updated

April 24, 2015

Sponsor

Ocean Spray Cranberries, Inc.

Collaborators

Biofortis Clinical Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01776021

Brief Title

Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

Official Title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ocean Spray Cranberries, Inc.

Collaborators

Biofortis Clinical Research, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the effects of a cranberry juice beverage on rates of Urinary tract infection (UTI) recurrence in women with a history of UTI.

Detailed Description

Urinary tract infections (UTI) are the second most common infection of any organ system and the most common urological disease in the United States, with a total annual cost of more than $3.5 billion. Although UTIs can occur in both men and women, they are about 50 times more common in adult women than adult men. It is estimated that 25% of women diagnosed with a primary UTI will suffer a recurrence within two to three months. While no universal definition has been accepted, recurrent UTI is usually defined as three episodes in the last 12 months or two episodes in the last six months following initial infection. In an estimated 75 to 95% of cases of uncomplicated UTI, Escherichia coli (E. coli) is the underlying cause. Cranberries have historically been associated with urinary tract health, but only recently has the biologic plausibility of cranberry use in the prevention of UTI been addressed. Current research suggests that A-type proanthocyanidins, a specific class of polyphenolic compounds found uniquely abundant in cranberries, inhibit adhesion of bacteria (including multidrug resistant E.coli) to cultured epithelial cells of the urinary tract. This study will compare the effects of a cranberry juice beverage vs placebo on rates of UTI recurrence in women with a history of UTI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections, Infection, Urologic Diseases

Keywords

Urinary tract infection, Recurrent urinary tract infection, Cranberry, Prevention, E-coli

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

330 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cranberry juice

Arm Type

Active Comparator

Arm Description

cranberry juice beverage at a dose of one 8 oz. beverage per day for six months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo beverage at a dose of one 8 oz. beverage per day for six months

Intervention Type

Other

Intervention Name(s)

cranberry juice

Intervention Description

cranberry juice beverage at a dose of one 8 oz. beverage per day for six months

Intervention Type

Other

Intervention Name(s)

placebo beverage

Intervention Description

placebo beverage at a dose of one 8 oz. beverage per day for six months

Primary Outcome Measure Information:

Title

The primary outcome variable will be UTI incidence density, defined as the semi-annualized number of UTIs in each group, adjusted for susceptible time under observation.

Time Frame

six months

Secondary Outcome Measure Information:

Title

Time Frame

six months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject has had at least 2 episodes of a UTI treated by a healthcare professional in the last year and at least 1 treated UTI within the last 6 months. Subject is willing to avoid listed Vaccinium products (including cranberry juice, cranberries, craisins, blueberries, cranberry/blueberry powders, pills, or supplements, probiotics) for 2 weeks prior to enrollment and throughout intervention. Subject agrees to avoid probiotic dietary supplements for 2 weeks prior to enrollment and throughout intervention. Subject agrees to limit all probiotic-containing foods/yogurt and yogurt-containing products to no more than an 8 oz serving/d within 2 weeks prior to enrollment and throughout intervention. Subject is willing to limit all soda, pop or energy drinks (diet or regular sweetened) to < 20 oz/d within 2 weeks prior to and throughout intervention. Exclusion Criteria: Subject has an in-dwelling catheter, polycystic disease, interstitial cystitis, previous urological surgery, stones, or anatomical abnormalities of the urinary tract, spinal cord injury, immuno-compromised conditions, severe renal impairment, or multiple sclerosis. Subject has a history of antibiotic prophylaxis use for UTI. A 2-week washout period prior to enrollment will be allowed. Subject has a body mass index (BMI) >40.0 kg/m2. Subjects with diabetes mellitus and HbA1C >8.0% prior to enrollment. Subject has diabetes mellitus treated with insulin. Subject has an active infection or sign/symptoms of an infection (i.e., including a UTI). Subject has used oral anti-coagulants within the last 4 weeks. Subject has a history or presence of cancer in the prior two years, except for nonmelanoma skin cancer. Subject is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin Maki, PhD

Organizational Affiliation

Biofortis Clinical Research, Inc.

Official's Role

Study Director

Facility Information:

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32123

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

City

Summerfield

State/Province

Florida

ZIP/Postal Code

34491

Country

United States

Facility Name

Ocean Spray Cranberries Research Sites

City

Addison

State/Province

Illinois

ZIP/Postal Code

60101

Country

United States

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

Pleasant Grove

State/Province

Utah

ZIP/Postal Code

84062

Country

United States

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33596852

Citation

Straub TJ, Chou WC, Manson AL, Schreiber HL 4th, Walker BJ, Desjardins CA, Chapman SB, Kaspar KL, Kahsai OJ, Traylor E, Dodson KW, Hullar MAJ, Hultgren SJ, Khoo C, Earl AM. Limited effects of long-term daily cranberry consumption on the gut microbiome in a placebo-controlled study of women with recurrent urinary tract infections. BMC Microbiol. 2021 Feb 18;21(1):53. doi: 10.1186/s12866-021-02106-4.

Results Reference

derived

PubMed Identifier

27251185

Citation

Maki KC, Kaspar KL, Khoo C, Derrig LH, Schild AL, Gupta K. Consumption of a cranberry juice beverage lowered the number of clinical urinary tract infection episodes in women with a recent history of urinary tract infection. Am J Clin Nutr. 2016 Jun;103(6):1434-42. doi: 10.3945/ajcn.116.130542. Erratum In: Am J Clin Nutr. 2017 Aug;106(2):708.

Results Reference

derived

Learn more about this trial

Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

We'll reach out to this number within 24 hrs