Cranberry and Quillaja on Symptoms of Uncomplicated UTI

Phase 2

Terminated

• Conditions: UTI; UTI - Lower Urinary Tract Infection; Urinary Tract Infections
• Interventions: Other: Pacran and Sapnov P quillaja

• Registration Number: NCT04496726
• Lead Sponsor: Lawson Health Research Institute

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 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 Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Study Start: 2021-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cranberry and Quillaja	Pacran and Sapnov P quillaja	one 450mg cranberry capsule and one 50mg quillaja capsule in the morning and evening for 14 days.

Primary Outcome Measures

Name	Time	Method
Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA)	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.
Time to UTI antibiotic initiation	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.

Secondary Outcome Measures

Name	Time	Method
Microbiome changes prior to and post antibiotic initiation	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).

Trial Locations

Locations (1)

St. Joseph's Health Care London; 🇨🇦 London, Ontario, Canada