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Urinary Tract InfectionsPhase 2NCT04496726

Cranberry and Quillaja on Symptoms of Uncomplicated UTI

A Phase 2 study testing Pacran and Sapnov P quillaja in people with Urinary Tract Infections and UTI, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Pacran and Sapnov P quillaja
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteCanada
Study dates
1 Jan 2021to 1 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Health Care London

    London, Ontario, N6A 4V2

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Pacran and Sapnov P quillaja
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pacran and Sapnov P quillajaOther

    Also called Cranberry, Quillaja, Pacran, Naturex

    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.

Study groups in NCT04496726
Study groupRoleWhat they receive
Cranberry and QuillajaExperimentalone 450mg cranberry capsule and one 50mg quillaja capsule in the morning and evening for 14 days.
Receives: Other: Pacran and Sapnov P quillaja

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 days

  2. 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.

    Measured: 14 days

Secondary outcomes (1)

  1. Microbiome changes prior to and post antibiotic initiation

    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).

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2020
  2. Study start1 Jan 2021
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Why it stopped: Failure to recruit

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single site, single group prospective cohort study
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04496726
Sponsor's protocol ID
Pro00043294
Status last verified
Jan 2024
First submitted
29 Jul 2020
Last updated
12 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19195714

  • 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.

    PubMed 20443158

  • 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.

    PubMed 16055161

  • 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.

    PubMed 26268913

  • 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.

    PubMed 28959520

  • 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.

    PubMed 30621160

  • 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.

    PubMed 27819292

  • 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.

    PubMed 30807432

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pacran and Sapnov P quillaja in people with Urinary Tract Infections and UTI, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04496726, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.

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