Cranberry on Urinary Tract Infections

Urinary Tract Infection Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate in Preventing Recurrent Urinary Tract Infections in Adult Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01881165
• Other study ID #: H13-01491
• Status: Withdrawn
• Phase: Phase 4
• First received: June 17, 2013
• Last updated: December 12, 2014
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women who consume it. About 150 adult women will participate in this study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or a placebo for 12 months. We expect cranberry supplement to have better results than the placebo. Subjects will not know which supplement they are taking. The primary outcome is the number of UTIs over 12 months.

Description:

Participants will attend their first study visit at a clinic at UBC. They will be randomized to the cranberry capsule or placebo. Participants will be instructed to consume the assigned supplement for the next 12 months. A calendar will be provided to record compliance and recurrent UTI. Participants will also record any side effects. They will be phoned each month to encourage participation and adherence. At 8 weeks and 6 months, they will be asked to return to the clinic to complete a midline questionnaire which will ask about any recurrent UTIs experienced. More supplements will be provided at their 6-month visit. At 12 months, participants will return to the clinic to complete an endline questionnaire. They will return any leftover supplements, calendar and side effect diary. If participants withdraw from the study, they will still be encouraged to return at 12 months to complete the survey to allow for intent-to-treat analysis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding

• Are sexually active

Exclusion Criteria:

• Current UTI

• Pregnant or breastfeeding or planning a pregnancy in the next 12 months

• A known allergy or intolerance to cranberry-containing products

• A history of renal stones and/or renal transplantation

• Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes

• Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement

• Intermittent or indwelling catheterization

• Any anatomic abnormalities of the urinary tract

• The use of any antibiotics within 2 weeks before study entry

• The use of any natural health products, including herbs, homeopathic products, or other forms of cranberry supplements within 2 weeks before study entry

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Cranberry

• Placebo

Locations

Country	Name	City	State
Canada	The University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of urinary tract infections	The number of symptomatic UTIs over 12 months (defined by self-report as having one or more of the following symptoms: dysuria, frequency, urgency, hematuria, supra-pubic pressure or fever), the proportion of participants with at least 1 symptomatic UTI, the median time to the first UTI	12 months	No
Secondary	Side effects		12 months	Yes