Status:
TERMINATED
Cranberry and Quillaja on Symptoms of Uncomplicated UTI
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Urobiome Therapeutics
St. Joseph's Health Care London
Conditions:
Urinary Tract Infections
UTI
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
This study will investigate the effects of cranberry and quillaja capsules on symptoms of uncomplicated urinary tract infections.
Detailed Description
Urinary tract infection (UTI) is one of the most common bacterial infections in humans and it disproportionately affects women. Currently there are only a few alternatives to antibiotics for treatment...
Eligibility Criteria
Inclusion
- Pre-menopausal women 18 years and over
- Presenting with typical symptoms of an uncomplicated UTI
- Positive leukocyte or nitrite on in-office urine dipstick confirmed
- Able to swallow capsules
- Willing and able to fill out/ answer questionnaires and comply with the study requirement
- Willing to initiate clinically prescribed antibiotic therapy (typically 5-day antibiotic).
- Provided written informed consent
- BMI \>17.5kg m2 and \<35kg m2
Exclusion
- 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,
- Allergy to cranberry, tree bark, or quillaja.
- Use of any antibacterial supplements or products, that in the opinion of the Medical Investigator may interfere with the study outcomes, within 28 days of Day 1
- A history of \>5 UTIs in the last 6 months (confirmed by self-report or health professional)
- Use of antibiotics or antibiotics for prophylaxis to treat a UTI within 28 days of Day 1
- Women of child bearing potential not willing to use adequate and effective methods of contraception throughout the study, in the opinion of the Investigator
- Positive urine dipstick pregnancy test at screening on Day 1, currently pregnant and/or breastfeeding
- History of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients
- History of pyelonephritis or reflux
- Presence of an intermittent or indwelling urinary catheter
- Anatomical abnormalities of the urinary tract (self-reported)
- History of or known clinically significant renal or urological disease (self-reported), at the discretion of the investigator
- History of or known clinically significant cardiac disease, at the discretion of the investigator
- History of or known clinically significant liver disease, at the discretion of the investigator
- History of or known clinically significant gastrointestinal disease, at the discretion of the investigator
- History of or known metabolic disorder or diabetes
- History of or known incomplete emptying of bladder
- 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
- Currently hospitalized or any planned hospitalizations within the study period.
- Immunocompromised participants or participants receiving immunosuppressive medication
- Currently taking warfarin or has received Warfarin within 28 days of Day 1
- Received an investigational drug within 28 days of Day 1 (pills, juices or supplements)
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04496726
Start Date
January 1 2021
End Date
June 1 2023
Last Update
January 12 2024
Active Locations (1)
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1
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2