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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; 18(1):29BU

Abstract

BACKGROUND

Urinary tract infections (UTIs) are amongst the most common bacterial infections affecting women. Although antibiotics are the treatment of choice for UTI, cranberry derived products have been used for many years to prevent UTIs, with limited evidence as to their efficacy. Our objective is to assess the efficacy of a cranberry extract capsule standardized in A-type linkage proanthocyanidins (PACs) for the prevention of recurrent urinary tract infection.

METHODS

We will perform a 1:1 randomized, controlled, double blind clinical trial in women aged 18 years or more who present ≥2 UTIs in 6 months or ≥ 3 UTIs in 12 months. One hundred and forty-eight women will be recruited and randomized in two groups to either receive an optimal dose of cranberry extract quantified and standardized in PACs (2 × 18.5 mg PACs per day) or a control dose (2 × 1 mg PACs per day). The primary outcome for the trial is the mean number of new symptomatic UTIs in women during a 6-month intervention period. Secondary outcomes are: (1) To evaluate the mean number of new symptomatic UTIs with pyuria as demonstrated by a positive leucocyte esterase test; (2) To detect the mean number of new symptomatic culture-confirmed UTIs; (3) To quantify urinary PACs metabolites in women who take a daily dose of 37 mg PACs per day compared to women who take a daily dose of 2 mg per day for 6 months; (4) To characterize women who present recurrent UTI based on known risk factors for recurrent UTI; (5) To describe the side effects of daily intake of cranberry extract containing 37 mg PACs compared to 2 mg PACs. This report provides comprehensive methodological data for this randomized controlled trial.

DISCUSSION

The results of this trial will inform urologists, gynaecologists, family physicians and other healthcare professionals caring for healthy women with recurrent UTI, as to the benefits of daily use of an optimal dose of cranberry extract for the prevention of recurrent UTI.

TRIAL REGISTRATION

Clinicaltrials.gov, identifier: NCT02572895 October 8th 2015.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, Laval University, CHU de Québec - Université Laval, 2705, boulevard Laurier, Local A1385, Québec, Québec, G1V 4G2, Canada. Institute of Nutrition and Functional Foods, Laval University, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.Institute of Nutrition and Functional Foods, Laval University, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.Institute of Nutrition and Functional Foods, Laval University, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.Institute of Nutrition and Functional Foods, Laval University, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.Rutgers University, 125A Lake Oswego Rd., Chatsworth, NJ, 08019, USA.Department of Obstetrics and Gynaecology, Laval University, CHU de Québec - Université Laval, 2705, boulevard Laurier, Local A1385, Québec, Québec, G1V 4G2, Canada. sylvie.dodin@fmed.ulaval.ca. Institute of Nutrition and Functional Foods, Laval University, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada. sylvie.dodin@fmed.ulaval.ca.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29716563

Citation

Asma, Babar, et al. "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 Urology, vol. 18, no. 1, 2018, p. 29.
Asma B, Vicky L, Stephanie D, et al. 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;18(1):29.
Asma, B., Vicky, L., Stephanie, D., Yves, D., Amy, H., & Sylvie, D. (2018). 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 Urology, 18(1), p. 29. doi:10.1186/s12894-018-0342-7.
Asma B, et al. 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. PubMed PMID: 29716563.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Asma,Babar, AU - Vicky,Leblanc, AU - Stephanie,Dudonne, AU - Yves,Desjardins, AU - Amy,Howell, AU - Sylvie,Dodin, Y1 - 2018/05/02/ PY - 2017/06/16/received PY - 2018/04/18/accepted PY - 2018/5/3/entrez PY - 2018/5/3/pubmed PY - 2018/9/27/medline KW - Antioxidants KW - Cranberry KW - Prevention KW - Proanthocyanidins KW - Recurrent urinary tract infection KW - Vaccinium macrocarpon KW - Women’s health SP - 29 EP - 29 JF - BMC urology JO - BMC Urol VL - 18 IS - 1 N2 - BACKGROUND: Urinary tract infections (UTIs) are amongst the most common bacterial infections affecting women. Although antibiotics are the treatment of choice for UTI, cranberry derived products have been used for many years to prevent UTIs, with limited evidence as to their efficacy. Our objective is to assess the efficacy of a cranberry extract capsule standardized in A-type linkage proanthocyanidins (PACs) for the prevention of recurrent urinary tract infection. METHODS: We will perform a 1:1 randomized, controlled, double blind clinical trial in women aged 18 years or more who present ≥2 UTIs in 6 months or ≥ 3 UTIs in 12 months. One hundred and forty-eight women will be recruited and randomized in two groups to either receive an optimal dose of cranberry extract quantified and standardized in PACs (2 × 18.5 mg PACs per day) or a control dose (2 × 1 mg PACs per day). The primary outcome for the trial is the mean number of new symptomatic UTIs in women during a 6-month intervention period. Secondary outcomes are: (1) To evaluate the mean number of new symptomatic UTIs with pyuria as demonstrated by a positive leucocyte esterase test; (2) To detect the mean number of new symptomatic culture-confirmed UTIs; (3) To quantify urinary PACs metabolites in women who take a daily dose of 37 mg PACs per day compared to women who take a daily dose of 2 mg per day for 6 months; (4) To characterize women who present recurrent UTI based on known risk factors for recurrent UTI; (5) To describe the side effects of daily intake of cranberry extract containing 37 mg PACs compared to 2 mg PACs. This report provides comprehensive methodological data for this randomized controlled trial. DISCUSSION: The results of this trial will inform urologists, gynaecologists, family physicians and other healthcare professionals caring for healthy women with recurrent UTI, as to the benefits of daily use of an optimal dose of cranberry extract for the prevention of recurrent UTI. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT02572895 October 8th 2015. SN - 1471-2490 UR - https://www.unboundmedicine.com/medline/citation/29716563/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_ L2 - https://bmcurol.biomedcentral.com/articles/10.1186/s12894-018-0342-7 DB - PRIME DP - Unbound Medicine ER -