Cranberry on Urinary Tract Infections

University of British Columbia

Status and phase

Withdrawn

Phase 4

Conditions

Urinary Tract Infection

Treatments

Drug: Cranberry

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01881165

H13-01491

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Volunteers

Accepts Healthy Volunteers

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