Urinary Tract InfectionsPhase 1PACCANNNCT02572895
Cranberry Extract and Urinary Infection Prevention: a Clinical Trial
A Phase 1 study testing Cranberry extract in people with Urinary Tract Infections, run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cranberry extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Laval University
Québec, Quebec, G1V 0A6
Vicky Leblanc, Dt.P., Ph.D., 418-656-2131 ext. 2336, vicky.leblanc.1@ulaval.ca
Sylvie Dodin, M.Sc., MD., 418-525-4307, sylvie.dodin@ogy.ulaval.ca
About this study
Official title: Recurrent Urinary Tract Infection Prevention With Biologic Cranberry Extract Intake Standardized in Proanthocyanidins: A Double-blind Clinical Trial
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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Cranberry extract
- Keywords
- Cranberry, Proanthocyanidins, Urinary catabolites
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry extractDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimal dose | Active comparator | One capsule with a proanthocyanidins standardized cranberry extract of 18,5 mg twice a day, i.e. in the morning and at night. Receives: Dietary Supplement: Cranberry extract |
| Control dose | Placebo comparator | One capsule with a proanthocyanidins standardized cranberry extract of 1 mg twice a day, i.e. in the morning and at night. Receives: Dietary Supplement: Cranberry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of urinary tract infections
Measured: Within a 6-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, Nutra Canada
- Responsible party
- Principal investigator, Sylvie Dodin, Laval University
- Investigators
- Sylvie Dodin, M.Sc., MD., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572895
- Sponsor's protocol ID
- PACCANN_2015
- Acronym
- PACCANN
- Status last verified
- Sep 2016
- First submitted
- 8 Oct 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33757474Asma 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.
PubMed 29716563
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Urinary Tract Infection Prevention With Biologic Cranberry Extract Intake Standardized in Proanthocyanidins: A Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02572895
- Acronym / sponsor ID
- PACCANN / PACCANN_2015
- Conditions
- Urinary Tract Infections
- Keywords
- Cranberry, Proanthocyanidins, Urinary catabolites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, Nutra Canada
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal dose | Active comparator | Dietary Supplement: Cranberry extractOne 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 comparator | Dietary Supplement: Cranberry extractOne capsule with a proanthocyanidins standardized cranberry extract of 1 mg twice a day, i.e. in the morning and at night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry extractThe 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. | Dietary supplement | Control dose, Optimal dose |
Primary outcome
Mean number of urinary tract infections
Time frame: Within a 6-month period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Derived from this study: PubMed 33757474Babar 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.
- Derived from this study: PubMed 29716563Asma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Dodin, M.Sc., MD. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cranberry extract in people with Urinary Tract Infections, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicky Leblanc, Dt.P., Ph.D. (418-656-2131 ext. 2336, vicky.leblanc.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of urinary tract infections (time frame: Within a 6-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02572895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.