Cranberry Extract and Urinary Infection Prevention: a Clinical Trial
PACCANN
Recurrent Urinary Tract Infection Prevention With Biologic Cranberry Extract Intake Standardized in Proanthocyanidins: A Double-blind Clinical Trial
1 other identifier
interventional
140
1 country
1
Brief Summary
The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs), compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs during a 6-month follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 9, 2016
September 1, 2016
1.8 years
October 8, 2015
September 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean number of urinary tract infections
Within a 6-month period
Study Arms (2)
Optimal dose
ACTIVE COMPARATOROne capsule with a proanthocyanidins standardized cranberry extract of 18,5 mg twice a day, i.e. in the morning and at night.
Control dose
PLACEBO COMPARATOROne capsule with a proanthocyanidins standardized cranberry extract of 1 mg twice a day, i.e. in the morning and at night.
Interventions
The aim of this clinical trial is to assess efficacy of an optimal dose of cranberry extract compared to a control dose on mean number of new UTIs for a 6-month period follow-up in women. Participants will be randomly assigned to the optimal dose or control dose treatment at their first visit at the Institute of Nutrition and Functional Foods. This intervention includes three visits at 0, 12 and 24 weeks. At the first visit, women will have to complete questionnaires to provide sociodemographic, medication and natural health products, health antecedents and quality of life information and to document risk factors related to UTIs. A 24-hour recall questionnaire about consumption of PACs will also be completed. A urinary sample analysis and culture as well as a pregnant test will also be performed. Compliance regarding capsules' intake and potential side effects will be documented. The completion of questionnaires and urinary measurements will be repeated at weeks 12 and 24.
Eligibility Criteria
You may qualify if:
- Healthy and sexually active women
- Aged between 18 to 45 years old
- Recurrence of 2 UTIs in the past 6 months or 3 in the past year
- Do not have consumed cranberry juice, polyphenols or antioxidant supplements in the last 2 weeks
- Internet access
You may not qualify if:
- Women who have personal history of acute or chronic renal failure
- Women who have personal history of urogenital system anomalies, urogenital tractus surgery or intestinal diseases causing malabsorption (e.g., Crohn and celiac diseases)
- Women who have personal history of kidney stones, taking anticoagulant medication or have taken anticoagulant medication in the last month
- Women presenting cranberry allergy or intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Ministry of Agriculture, Fisheries and Food, Quebeccollaborator
- Nutra Canadacollaborator
Study Sites (1)
Laval University
Québec, Quebec, G1V 0A6, Canada
Related Publications (2)
Babar A, Moore L, Leblanc V, Dudonne S, Desjardins Y, Lemieux S, Bochard V, Guyonnet D, Dodin S. High dose versus low dose standardized cranberry proanthocyanidin extract for the prevention of recurrent urinary tract infection in healthy women: a double-blind randomized controlled trial. BMC Urol. 2021 Mar 23;21(1):44. doi: 10.1186/s12894-021-00811-w.
PMID: 33757474DERIVEDAsma B, Vicky L, Stephanie D, Yves D, Amy H, Sylvie D. Standardised high dose versus low dose cranberry Proanthocyanidin extracts for the prevention of recurrent urinary tract infection in healthy women [PACCANN]: a double blind randomised controlled trial protocol. BMC Urol. 2018 May 2;18(1):29. doi: 10.1186/s12894-018-0342-7.
PMID: 29716563DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Dodin, M.Sc., MD.
Laval University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, M.Sc.
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 9, 2015
Study Start
August 1, 2015
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
September 9, 2016
Record last verified: 2016-09