High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection

Urinary Tract Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042273
• Other study ID #: PAC-001
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Swisse Wellness Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Dietary Supplement:
• High Strength Cranberry
Softgel capsule
• Placebo
Soy oil to match High Strength Cranberry Softgel Capsule

Locations

Country	Name	City	State
Australia	CSIRO Nutrition and Health Research Clinic	Adelaide	South Australia
Australia	Holdsworth House Medical Centre	Brisbane	Queensland
Australia	Griffith University Clinical Trial Unit (Griffith Health)	Gold Coast	Queensland
Australia	Monash Alfred Psychiatry Research Centre (MAPrc)	Melbourne	Victoria
Australia	Holdsworth House Medical Centre	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Swisse Wellness Pty Ltd	Commonwealth Scientific and Industrial Research Organisation, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of UTI	cultured confirmed UTIs at a level of >108cfu/L (105cfu/mL)	6 months