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

NCT ID: NCT01776021

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Urinary Tract Infections; Infection; Urologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

cranberry juice

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

Group Type: ACTIVE_COMPARATOR

cranberry juice

Intervention Type: OTHER

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo beverage

Intervention Type: OTHER

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

Interventions

cranberry juice

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

Intervention Type: OTHER

placebo beverage

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Subject agrees to avoid probiotic dietary supplements for 2 weeks prior to enrollment and throughout intervention.

4. 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.

5. 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

1. 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.

2. Subject has a history of antibiotic prophylaxis use for UTI. A 2-week washout period prior to enrollment will be allowed.

3. Subject has a body mass index (BMI) >40.0 kg/m2.

4. Subjects with diabetes mellitus and HbA1C >8.0% prior to enrollment.

5. Subject has diabetes mellitus treated with insulin.

6. Subject has an active infection or sign/symptoms of an infection (i.e., including a UTI).

7. Subject has used oral anti-coagulants within the last 4 weeks.

8. Subject has a history or presence of cancer in the prior two years, except for nonmelanoma skin cancer.

9. 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biofortis Clinical Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Ocean Spray Cranberries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Maki, PhD

Role: STUDY_DIRECTOR

Biofortis Clinical Research, Inc.

Locations

Chandler, Arizona, United States

Scottsdale, Arizona, United States

San Diego, California, United States

Santa Rosa, California, United States

Denver, Colorado, United States

Edgewater, Florida, United States

Miami, Florida, United States

Summerfield, Florida, United States

Ocean Spray Cranberries Research Sites

Addison, Illinois, United States

Evanston, Illinois, United States

Edina, Minnesota, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Anderson, South Carolina, United States

Dallas, Texas, United States

Pleasant Grove, Utah, United States

Salt Lake City, Utah, United States

Countries

United States

References

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)

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.

Reference Type: DERIVED

PMID: 33596852 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27251185 (View on PubMed)

Other Identifiers

PRV-1201

Identifier Type: -

Identifier Source: org_study_id