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Trial record 28 of 10344 for:    strength

High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection

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ClinicalTrials.gov Identifier: NCT03042273
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Commonwealth Scientific and Industrial Research Organisation, Australia
Information provided by (Responsible Party):
Swisse Wellness Pty Ltd

Brief Summary:
This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Dietary Supplement: High Strength Cranberry Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomised, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of High Strength Cranberry (Pacran®) in Women With Recurrent Urinary Tract Infections (Cystitis)
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Strength Cranberry
1 capsule of High Strength Cranberry (25,000mg Vaccinium macrocarpon) orally daily for 6 months
Dietary Supplement: High Strength Cranberry
Softgel capsule
Other Name: 25,000mg Vaccinium macrocarpon

Placebo Comparator: Placebo
1 capsule of Matching Placebo orally daily for 6 months
Dietary Supplement: Placebo
Soy oil to match High Strength Cranberry Softgel Capsule
Other Name: Placebo (for High Strength Cranberry)




Primary Outcome Measures :
  1. Incidence of UTI [ Time Frame: 6 months ]
    cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females with a history of recurrent UTIs
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Females aged 18-65 years, inclusive
  2. A history of recurrent urinary tract infection defined as ≥3 UTIs in the last year OR at least 2 UTIs occurring in the last 6 months. Each infection requires confirmation by a health professional
  3. Willing to answer questionnaires and comply with the study requirements
  4. Ability to swallow capsules
  5. Provided Written Informed Consent
  6. BMI >17.5kg m2 and <35kg m2

Exclusion Criteria:

  1. Microbial growth on urine culture of ≥107 cfu/L (104cfu/mL) within 7 days of Day 1
  2. A history of >5 UTIs in the last 6 months (confirmed by self-report or health professional)
  3. Use of antibiotics or antibiotics for prophylaxis within 28 days of Day 1
  4. Use of any antibacterial products, that in the opinion of the Medical Investigator may interfere with the study outcomes, within 28 days of Day 1
  5. Regular use of Vaccinium containing products (e.g. all forms of blueberries, cranberries, bilberry, lingonberry , etc i.e fruit, dried fruit, pills, juices or supplements) within 28 days of Day 1 at the discretion of the Medical Investigator
  6. Presence of an intermittent or indwelling urinary catheter
  7. Anatomical abnormalities of the urinary tract
  8. History of or known clinically significant renal or urological disease(self-reported)
  9. Positive urine dipstick pregnancy test at screening onDay 1, currently pregnant and/or breastfeeding
  10. Women of Childbearing potential not willing to use adequate and effective methods of contraception throughout the study
  11. Women of child bearing potential that have not been using effective methods of contraception for 14 days prior to Day 1
  12. History of or known clinically significant cardiac disease
  13. History of or known clinically significant liver disease
  14. History of or known clinically significant gastrointestinal disease
  15. History of or known metabolic disorder or diabetes
  16. History or presence of alcohol or illicit drug abuse,any surgical history, clinical condition or organ dysfunction that in the opinion of the Medical Investigator may affect the participant's ability to participate in the study or the study results
  17. Currently hospitalised or any planned hospitalisations within 1 month following the last dose of study product
  18. Immunocompromised participants or participants receiving immunosuppressive medication
  19. History of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients
  20. Currently taking warfarin or has received Warfarin within 28 days of Day 1
  21. Received an investigational drug within 28 days of Day 1

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): NCT03042273


Contacts
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Contact: Bianca Benassi, PhD +61 8 8303 8982 Bianca.Benassi@csiro.au

Locations
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Australia, New South Wales
Holdsworth House Medical Centre Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Trina Vincent    02 8038 1044    Trina.Vincent@holdsworthhouse.com.au   
Principal Investigator: Mark Bloch         
Australia, Queensland
Holdsworth House Medical Centre Active, not recruiting
Brisbane, Queensland, Australia, 4006
Griffith University Clinical Trial Unit (Griffith Health) Recruiting
Gold Coast, Queensland, Australia, 4222
Contact: Donna Reeves    0435 659 063    donna.reeves@griffith.edu.au   
Contact: Claire Williams    0458 269 203    claire.williams@griffith.edu.au   
Principal Investigator: Elizabeth Fitzmaurice         
Australia, South Australia
CSIRO Nutrition and Health Research Clinic Recruiting
Adelaide, South Australia, Australia
Contact: Bianca Benassi-Evans, PhD    +61 8 83038982      
Australia, Victoria
Monash Alfred Psychiatry Research Centre (MAPrc) Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Anthony DeCastella, MBA    +61 3 9076 6554    anthony.decastella@monash.edu   
Contact: Alex Conway, BParaMedSc    + 61 409 830 990    alex.conway@monash.edu   
Principal Investigator: Jayashri Kulkarni, Prof         
Sub-Investigator: Abdul-Rahman Hudaib, MBBS         
Sponsors and Collaborators
Swisse Wellness Pty Ltd
Commonwealth Scientific and Industrial Research Organisation, Australia
Investigators
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Principal Investigator: Welma Stonehouse, PhD CSIRO

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Responsible Party: Swisse Wellness Pty Ltd
ClinicalTrials.gov Identifier: NCT03042273     History of Changes
Other Study ID Numbers: PAC-001
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swisse Wellness Pty Ltd:
recurrent
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases