Cranberry Juice for Treatment of Urinary Tract Infections

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Urinary Tract Infections

Treatments: Drug: Cranberry juice; Dietary Supplement: Placebo cranberry juice

Study type: Interventional

Funder types: NIH

Identifiers

NCT00093054

R01AT002086

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 319 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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319 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Cranberry juice

Treatment:

Drug: Cranberry juice

2

Placebo Comparator group

Description:

Placebo juice

Treatment:

Dietary Supplement: Placebo cranberry juice