Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
150

Inclusion Criterias

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

Exclusion Criterias

A known allergy or intolerance to cranberry-containing products
Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
Pregnant or breastfeeding or planning a pregnancy in the next 12 months
...
A known allergy or intolerance to cranberry-containing products
Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
Pregnant or breastfeeding or planning a pregnancy in the next 12 months
Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
A history of renal stones and/or renal transplantation
Current UTI
Any anatomic abnormalities of the urinary tract
Intermittent or indwelling catheterization
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

Summary

Conditions
Urinary Tract Infection
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Prevention

Participation Requirements

Age
Younger than 125 years
Gender
Only females

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. Participant...

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.

Inclusion Criterias

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

Exclusion Criterias

A known allergy or intolerance to cranberry-containing products
Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
Pregnant or breastfeeding or planning a pregnancy in the next 12 months
...
A known allergy or intolerance to cranberry-containing products
Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
Pregnant or breastfeeding or planning a pregnancy in the next 12 months
Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
A history of renal stones and/or renal transplantation
Current UTI
Any anatomic abnormalities of the urinary tract
Intermittent or indwelling catheterization
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

Locations

Vancouver, British Columbia, V6T 1Z4
Vancouver, British Columbia, V6T 1Z4

Tracking Information

NCT #
NCT01881165
Collaborators
Not Provided
Investigators
  • Principal Investigator: Tim Green, PhD University of British Columbia
  • Tim Green, PhD University of British Columbia