Cranberry and Quillaja on Symptoms of Uncomplicated UTI

NCT04496726 | Terminated Phase 2

• 1 other identifier: Pro00043294
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infections; UTI; UTI - Lower Urinary Tract Infection

Outcome Measures

Primary Outcomes (2)

• Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA)

  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

  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 Outcomes (1)

• Microbiome changes prior to and post antibiotic initiation

  14 days

Study Arms (1)

Cranberry and Quillaja

EXPERIMENTAL

one 450mg cranberry capsule and one 50mg quillaja capsule in the morning and evening for 14 days.

Other: Pacran and Sapnov P quillaja

Interventions

Pacran and Sapnov P quillaja OTHER

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.

Also known as: Cranberry, Quillaja, Pacran, Naturex, Sapnov P, Quillaia extract type II

Cranberry and Quillaja

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Urobiome Therapeutics: collaborator
• St. Joseph's Health Care London: collaborator

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

Related Publications (8)

• Falagas ME, Kotsantis IK, Vouloumanou EK, Rafailidis PI. Antibiotics versus placebo in the treatment of women with uncomplicated cystitis: a meta-analysis of randomized controlled trials. J Infect. 2009 Feb;58(2):91-102. doi: 10.1016/j.jinf.2008.12.009. Epub 2009 Feb 4.

  PMID: 19195714 BACKGROUND

• Pappas E, Schaich KM. Phytochemicals of cranberries and cranberry products: characterization, potential health effects, and processing stability. Crit Rev Food Sci Nutr. 2009 Oct;49(9):741-81. doi: 10.1080/10408390802145377.

  PMID: 20443158 BACKGROUND

• Howell AB, Reed JD, Krueger CG, Winterbottom R, Cunningham DG, Leahy M. A-type cranberry proanthocyanidins and uropathogenic bacterial anti-adhesion activity. Phytochemistry. 2005 Sep;66(18):2281-91. doi: 10.1016/j.phytochem.2005.05.022.

  PMID: 16055161 BACKGROUND

• Vostalova J, Vidlar A, Simanek V, Galandakova A, Kosina P, Vacek J, Vrbkova J, Zimmermann BF, Ulrichova J, Student V. Are High Proanthocyanidins Key to Cranberry Efficacy in the Prevention of Recurrent Urinary Tract Infection? Phytother Res. 2015 Oct;29(10):1559-67. doi: 10.1002/ptr.5427. Epub 2015 Aug 13.

  PMID: 26268913 BACKGROUND

• Sarkhel S. Evaluation of the anti-inflammatory activities of Quillaja saponaria Mol. saponin extract in mice. Toxicol Rep. 2015 Dec 1;3:1-3. doi: 10.1016/j.toxrep.2015.11.006. eCollection 2016.

  PMID: 28959520 BACKGROUND

• Fleck JD, Betti AH, da Silva FP, Troian EA, Olivaro C, Ferreira F, Verza SG. Saponins from Quillaja saponaria and Quillaja brasiliensis: Particular Chemical Characteristics and Biological Activities. Molecules. 2019 Jan 4;24(1):171. doi: 10.3390/molecules24010171.

  PMID: 30621160 BACKGROUND

• den Brok MH, Bull C, Wassink M, de Graaf AM, Wagenaars JA, Minderman M, Thakur M, Amigorena S, Rijke EO, Schrier CC, Adema GJ. Saponin-based adjuvants induce cross-presentation in dendritic cells by intracellular lipid body formation. Nat Commun. 2016 Nov 7;7:13324. doi: 10.1038/ncomms13324.

  PMID: 27819292 BACKGROUND

• Southworth E, Hochstedler B, Price TK, Joyce C, Wolfe AJ, Mueller ER. A Cross-sectional Pilot Cohort Study Comparing Standard Urine Collection to the Peezy Midstream Device for Research Studies Involving Women. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):e28-e33. doi: 10.1097/SPV.0000000000000693.

  PMID: 30807432 BACKGROUND

Related Links

• A Randomized, Double Blind, Controlled, Dose Dependent Clinical Trial to Evaluate the Efficacy of a Proanthocyanidin Standardized Whole Cranberry (Vaccinium macrocarpon) Powder on Infections of the Urinary Tract. Current Bioactive Compounds
• Quillaja Saponaria Extract; Exempt from the Requirement of a Tolerance
• AssayAssure Universal Urine Collection \& Transport Product

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Blayne Welk, MD

  St. Joseph's Healthcare London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single site, single group prospective cohort study

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)