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Cranberry Extract and Urinary Infection Prevention: a Clinical Trial (PACCANN)

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ClinicalTrials.gov Identifier: NCT02572895
Recruitment Status : Unknown
Verified September 2016 by Sylvie Dodin, Laval University.
Recruitment status was:  Recruiting
First Posted : October 9, 2015
Last Update Posted : September 9, 2016
Sponsor:
Collaborators:
Ministry of Agriculture, Fisheries and Food, Quebec
Nutra Canada
Information provided by (Responsible Party):
Sylvie Dodin, Laval University

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Dietary Supplement: Cranberry extract Phase 1

Detailed Description:
Cranberry juice, fruit (fresh and dried), functional foods, and cranberry dietary supplements are promoted for prevention of urinary tract infections (UTIs) on the basis of their content of cranberry proanthocyanidins (PACs) with "A-type" interflavan bonds. Several clinical trials have assessed efficacy of cranberry-derived products, essentially with cranberry juices, but discordant results have been found. Lack of compliance but mostly lack of standardization in product concentrations can account for the variability among results. Indeed, most clinical trials do not report quantity of PACs. According to most recent studies, quantification of PACs requiring standardized and reproducible methods should be at least 37 mg/day. It can be hypothesized that efficacy of cranberry extract in UTIs prevention among young women can be strongly increased using optimal dosage (standardized to 37 mg/day of PACs). The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent UTIs, efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Recurrent Urinary Tract Infection Prevention With Biologic Cranberry Extract Intake Standardized in Proanthocyanidins: A Double-blind Clinical Trial
Study Start Date : August 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Optimal dose
One capsule with a proanthocyanidins standardized cranberry extract of 18,5 mg twice a day, i.e. in the morning and at night.
Dietary Supplement: Cranberry extract
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.

Placebo Comparator: Control dose
One capsule with a proanthocyanidins standardized cranberry extract of 1 mg twice a day, i.e. in the morning and at night.
Dietary Supplement: Cranberry extract
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.




Primary Outcome Measures :
  1. Mean number of urinary tract infections [ Time Frame: Within a 6-month period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572895


Contacts
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Contact: Vicky Leblanc, Dt.P., Ph.D. 418-656-2131 ext 2336 vicky.leblanc.1@ulaval.ca
Contact: Sylvie Dodin, M.Sc., MD. 418-525-4307 sylvie.dodin@ogy.ulaval.ca

Locations
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Canada, Quebec
Laval University Recruiting
Québec, Quebec, Canada, G1V 0A6
Contact: Vicky Leblanc, Dt.P., Ph.D.    418-656-2131 ext 2336    vicky.leblanc.1@ulaval.ca   
Contact: Sylvie Dodin, M.Sc., MD.    418-525-4307    sylvie.dodin@ogy.ulaval.ca   
Sponsors and Collaborators
Laval University
Ministry of Agriculture, Fisheries and Food, Quebec
Nutra Canada
Investigators
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Principal Investigator: Sylvie Dodin, M.Sc., MD. Laval University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sylvie Dodin, MD, M.Sc., Laval University
ClinicalTrials.gov Identifier: NCT02572895    
Other Study ID Numbers: PACCANN_2015
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Keywords provided by Sylvie Dodin, Laval University:
Cranberry
Proanthocyanidins
Urinary catabolites
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases