Cranberry and Quillaja on Symptoms of Uncomplicated UTI

January 10, 2024 updated by: Lawson Health Research Institute

A Proof-of-concept, Feasibility Study to Investigate the Effect of Cranberry and Quillaia Extract Type II on Symptoms in Women With Uncomplicated Urinary Tract Infection and to Study the Modulation of the Urinary and Gut Microbiome Pre- and Post-antibiotic Use

This study will investigate the effects of cranberry and quillaja capsules on symptoms of uncomplicated urinary tract infections.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 of UTI. Although symptomatic relief occurs more quickly in women treated with oral antibiotics for uncomplicated UTIs, patients appear to successfully resolve their UTI without antibiotic therapy. While antibiotics are the mainstay of therapy, there are growing concerns about collateral effects impacting healthy microbiomes and anti-bacterial resistance patterns. Recent estimates from the CDC indicate that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die as a result.

The proposed research fills a key knowledge gap that will be critical in determining the role of a non-antibiotic substance with the potential to treat UTIs by modulating the urinary and gut microbiome to restore health and minimize the reliance on traditional antibiotic therapy while also preventing antibiotic resistance. In addition, this study will provide early evidence of the short-term symptom and urinary and gut microbiome changes following ingestion of two botanical food substances (cranberry and quillaja) that have the potential for beneficial effects on the microbiome and UTI symptoms.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pre-menopausal women 18 years and over
  2. Presenting with typical symptoms of an uncomplicated UTI
  3. Positive leukocyte or nitrite on in-office urine dipstick confirmed
  4. Able to swallow capsules
  5. Willing and able to fill out/ answer questionnaires and comply with the study requirement
  6. Willing to initiate clinically prescribed antibiotic therapy (typically 5-day antibiotic).
  7. Provided written informed consent
  8. BMI >17.5kg m2 and <35kg m2

Exclusion Criteria:

  1. 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,
  2. Allergy to cranberry, tree bark, or quillaja.
  3. 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
  4. A history of >5 UTIs in the last 6 months (confirmed by self-report or health professional)
  5. Use of antibiotics or antibiotics for prophylaxis to treat a UTI within 28 days of Day 1
  6. Women of child bearing potential not willing to use adequate and effective methods of contraception throughout the study, in the opinion of the Investigator
  7. Positive urine dipstick pregnancy test at screening on Day 1, currently pregnant and/or breastfeeding
  8. History of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients
  9. History of pyelonephritis or reflux
  10. Presence of an intermittent or indwelling urinary catheter
  11. Anatomical abnormalities of the urinary tract (self-reported)
  12. History of or known clinically significant renal or urological disease (self-reported), at the discretion of the investigator
  13. History of or known clinically significant cardiac disease, at the discretion of the investigator
  14. History of or known clinically significant liver disease, at the discretion of the investigator
  15. History of or known clinically significant gastrointestinal disease, at the discretion of the investigator
  16. History of or known metabolic disorder or diabetes
  17. History of or known incomplete emptying of bladder
  18. 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
  19. Currently hospitalized or any planned hospitalizations within the study period.
  20. Immunocompromised participants or participants receiving immunosuppressive medication
  21. Currently taking warfarin or has received Warfarin within 28 days of Day 1
  22. Received an investigational drug within 28 days of Day 1 (pills, juices or supplements)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cranberry and Quillaja
one 450mg cranberry capsule and one 50mg quillaja capsule in the morning and evening for 14 days.
Other: Pacran and Sapnov P quillaja
Cranberry (450 mg) and quillaja (50 mg) capsules taken orally twice daily (morning and evening) for a total daily dose of 900 mg cranberry and 100 mg quillaja for 14 days. Nitrofurantoin 100 mg taken orally twice daily for five days as a rescue medication if symptoms do not subside.
Other Names:
  • Cranberry
  • Quillaja
  • Pacran
  • Naturex
  • Sapnov P
  • Quillaia extract type II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA)
Time Frame: 14 days
This questionnaire assesses the degree of symptoms and bother on a scale of 0 to 3, and has 3 domains of urinary regularity, problems with urination and pain associated with urination. The fourth domain includes the presence of hematuria. Subjects will complete the UTISA questionnaire every day for 14 days.
14 days
Time to UTI antibiotic initiation
Time Frame: 14 days
This will be assessed using study form, UTI Comfort Measure Assessment. Subjects will have access to a clinically prescribed UTI antibiotic, nitrofurantoin 100mg. Subjects will be asked to record each day their intake of any antibiotic during the study period.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome changes prior to and post antibiotic initiation
Time Frame: 14 days
This outcome measure can only be assessed for those participants that require antibiotic initiation. Changes in the entire bacterial community prior to and post antibiotic use will be assessed in the lab from faecal and urine samples collected by the participant. The microbes may vary by participant and the study will be looking at which ones present themselves in each case. Units of measure via culture are colony forming units per g (cfu/g).
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

St. Joseph's Health Care London
Urobiome Therapeutics

Investigators

  • Principal Investigator: Blayne Welk, MD, St. Joseph's Healthcare London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00043294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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