Urinary Tract Infection(UTI)Phase 2NCT06719115
A Clinical Trial to Investigate the Safety and Efficacy of D-Mannose on Symptoms of Urinary Tract Infection in Women
A Phase 2 study testing UClear in people with Urinary Tract Infection(UTI), run by KEB Nutraceuticals USA, Inc. at 1 site in Canada.
Trial summary
The objective of this acute study was to investigate the safety and efficacy of UClear for the resolution of urinary tract infection (UTI) symptoms in women. The main questions it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Tract Infection(UTI)
- What is being tested?
- UClear
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2023to 20 Jun 2024
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females between 18 and 75 years of age, inclusive, at screening
- Individuals not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
Show all 12Show fewer
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- At least two uncomplicated UTI symptoms defined by frequent, urgent, and painful urination, incomplete voiding, pelvic and low back pain, and blood in urine, as assessed by UTISA questionnaire
- Positive urine dip stick test for nitrites or leukocytes
- Agree to keep lifestyle, including dietary habits, physical activity patterns, and medications/supplements, consistent for the duration of the trial
- Provided voluntary, written, informed consent to participate in the study
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product, placebo, or rescue medication ingredients
- Clinical signs and symptoms of an upper UTI (ex. costovertebral pain or tenderness, nausea, vomiting, fever), as assessed by the QI
- Anatomical or functional urinary tract abnormalities and/or diagnosis of kidney or other urinary tract diseases/conditions, such as painful bladder syndrome, neurogenic bladder, and polycystic kidney disease, as assessed by the QI
- History of or current urological cancers
- Current use of an indwelling catheter or intermittent catheterization
Show all 25Show fewer
- Type I or Type II diabetes
- Unstable hypertension. Treatment on a stable dose of medication for at least three months will be considered by the QI
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least three months will be considered by the QI
- Self-reported confirmation of blood/bleeding disorders
- Individuals with an autoimmune disease or are immune compromised, as assessed by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of any significant diseases of the gastrointestinal tract, as assessed by the QI
- History of or current diagnosis of liver diseases as assessed by the QI
- Participants who are within three days of the end of their menstruation, menstruating, or anticipating menstruation during the study
- Major surgery in the past three months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Current use of prescribed medications, over-the-counter (OTC) medications, or supplements, food/ drinks which may affect the efficacy and/or safety of the IP (see Sections 12.4.6 and 12.4.7)
- Use of medical cannabinoid products
- Use of cannabinoid products and is unwilling to stop use for the duration of the study
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of D-Mannose on Symptoms of Urinary Tract Infection in Women
The objective of this acute study was to investigate the safety and efficacy of UClear for the resolution of urinary tract infection (UTI) symptoms in women. The main questions it aims to answer is:
- Is there a difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between UClear and placebo
- Is there a difference in change from baseline (Day 1) at Day 4 between UClear and placebo in Urinary Tract Infection Symptom Assessment (UTISA) symptom severity scores.
Participants will take UClear or placebo twice a day for 3 days with or without food, have 4 in clinical visits, and will be instructed to complete a quality of life (QoL) questionnaire during each visit and a UTISA questionnaire at follow-up (Day 7).
- Conditions
- Urinary Tract Infection(UTI)
- Being tested
- UClear, Placebo
- Keywords
- Uncomplicated urinary tract infection
- 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.
UClearDietary supplement
Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).
PlaceboOther
Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).
| Study group | Role | What they receive |
|---|---|---|
| UClear | Experimental | UClear contains 1.5g of D-Mannose. Participants will be instructed to take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit). The product should be completely dissolved in a full glass of water and participants are instructed to take one dose in the morning and one dose in the afternoon. If a dose was missed participants were instructed to take the missed dose as soon as they remembered. Participants were advised not to exceed two doses daily. Receives: Dietary Supplement: UClear |
| Placebo | Placebo comparator | Participants will be instructed to take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).The product should be completely dissolved in a full glass of water and participants are instructed to take one dose in the morning and one dose in the afternoon. If a dose was missed participants were instructed to take the missed dose as soon as they remembered. Participants were advised not to exceed two doses daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between D-mannose and placebo
The difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between D-mannose and placebo as defined as 0 points on all UTISA questionnaire components.
Measured: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in the frequency of urination
Measured: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in urgency of urination
Measured: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in painful/burning urination
Measured: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in incomplete voiding
Measured: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in pelvic pain
Measured: Day 1 to 4
The difference in change between D-mannose and placebo in UTISA symptom severity scores
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in blood in urine
Measured: Day 1 to 4
Secondary outcomes (14)
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo at Day 2
Measured: Day 1 to 2
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo at Day 3
Measured: Day 1 to 3
The difference in the change in symptom severity scores from baseline between D-mannose and placebo
The difference in the change in symptom severity scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 2
Measured: Day 1 to 2
The difference in the change in symptom severity scores from baseline between D-mannose and placebo
The difference in the change in symptom severity scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 3
Measured: Day 1 to 3
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 2
Measured: Day 1 to 2
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 3
Measured: Day 1 to 3
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo as assessed by UTISA questionnaire at Day 4
Measured: Day 1 to 4
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo at Day 2
Measured: Day 1 to 2
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo at Day 3
Measured: Day 1 to 3
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo at Day 4
Measured: Day 1 to 4
The difference in change of quality of life from baseline between D-mannose and placebo
The difference in change of quality of life from baseline between D-mannose and placebo assessed by the RAND SF-36 questionnaire at Day 2
Measured: Day 1 to 2
The difference in change of quality of life from baseline between D-mannose and placebo
The difference in change of quality of life from baseline between D-mannose and placebo assessed by the RAND SF-36 questionnaire at Day 3
Measured: Day 1 to 3
The difference in change of quality of life from baseline between D-mannose and placebo
The difference in change of quality of life from baseline between D-mannose and placebo assessed by the RAND SF-36 questionnaire at Day 4
Measured: Day 1 to 4
The difference in proportion of participants taking rescue medication up to Day 4 and/or during the follow-up period between D-mannose and placebo
Measured: Day 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start3 May 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection(UTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- KEB Nutraceuticals USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719115
- Sponsor's protocol ID
- 22KBCFD01
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of D-Mannose on Symptoms of Urinary Tract Infection in Women
- ClinicalTrials.gov ID
- NCT06719115
- Acronym / sponsor ID
- 22KBCFD01
- Conditions
- Urinary Tract Infection(UTI)
- Keywords
- Uncomplicated urinary tract infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- KEB Nutraceuticals USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 3 May 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this acute study was to investigate the safety and efficacy of UClear for the resolution of urinary tract infection (UTI) symptoms in women. The main questions it aims to answer is:
- Is there a difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between UClear and placebo
- Is there a difference in change from baseline (Day 1) at Day 4 between UClear and placebo in Urinary Tract Infection Symptom Assessment (UTISA) symptom severity scores.
Participants will take UClear or placebo twice a day for 3 days with or without food, have 4 in clinical visits, and will be instructed to complete a quality of life (QoL) questionnaire during each visit and a UTISA questionnaire at follow-up (Day 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UClear | Experimental | Dietary Supplement: UClearUClear contains 1.5g of D-Mannose. Participants will be instructed to take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit). The product should be completely dissolved in a full glass of water and participants are instructed to take one dose in the morning and one dose in the afternoon. If a dose was missed participants were instructed to take the missed dose as soon as they remembered. Participants were advised not to exceed two doses daily. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be instructed to take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).The product should be completely dissolved in a full glass of water and participants are instructed to take one dose in the morning and one dose in the afternoon. If a dose was missed participants were instructed to take the missed dose as soon as they remembered. Participants were advised not to exceed two doses daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Females between 18 and 75 years of age, inclusive, at screening
- Individuals not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
Key exclusion criteria (25 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product, placebo, or rescue medication ingredients
- Clinical signs and symptoms of an upper UTI (ex. costovertebral pain or tenderness, nausea, vomiting, fever), as assessed by the QI
- Anatomical or functional urinary tract abnormalities and/or diagnosis of kidney or other urinary tract diseases/conditions, such as painful bladder syndrome, neurogenic bladder, and polycystic kidney disease, as assessed by the QI
- History of or current urological cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UClearTake one dose twice a day for three days with or without food, starting on Day 1 (baseline visit). | Dietary supplement | UClear |
| PlaceboTake one dose twice a day for three days with or without food, starting on Day 1 (baseline visit). | Other | Placebo |
Primary outcome
The difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between D-mannose and placebo
Time frame: Day 1 to 4
The difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between D-mannose and placebo as defined as 0 points on all UTISA questionnaire components.
The difference in change between D-mannose and placebo in UTISA symptom severity scores
Time frame: Day 1 to 4
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in the frequency of urination
The difference in change between D-mannose and placebo in UTISA symptom severity scores
Time frame: Day 1 to 4
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in urgency of urination
The difference in change between D-mannose and placebo in UTISA symptom severity scores
Time frame: Day 1 to 4
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in painful/burning urination
The difference in change between D-mannose and placebo in UTISA symptom severity scores
Time frame: Day 1 to 4
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in incomplete voiding
The difference in change between D-mannose and placebo in UTISA symptom severity scores
Time frame: Day 1 to 4
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in pelvic pain
The difference in change between D-mannose and placebo in UTISA symptom severity scores
Time frame: Day 1 to 4
The difference in change from baseline (Day 1) at Day 4 between D-mannose and placebo in blood in urine
14 secondary outcomes
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo
Time frame: Day 1 to 2
The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo
Time frame: Day 1 to 3
The difference in the change in symptom severity scores from baseline between D-mannose and placebo
Time frame: Day 1 to 2
The difference in the change in symptom severity scores from baseline between D-mannose and placebo
Time frame: Day 1 to 3
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
Time frame: Day 1 to 2
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
Time frame: Day 1 to 3
The difference in the change in UTISA bother scores from baseline between D-mannose and placebo
Time frame: Day 1 to 4
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
Time frame: Day 1 to 2
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
Time frame: Day 1 to 3
The difference in change in urine culture (multiple bacterial strains) from baseline between D-mannose and placebo
Time frame: Day 1 to 4
The difference in change of quality of life from baseline between D-mannose and placebo
Time frame: Day 1 to 2
The difference in change of quality of life from baseline between D-mannose and placebo
Time frame: Day 1 to 3
The difference in change of quality of life from baseline between D-mannose and placebo
Time frame: Day 1 to 4
The difference in proportion of participants taking rescue medication up to Day 4 and/or during the follow-up period between D-mannose and placebo
Time frame: Day 1 to 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UClear in people with Urinary Tract Infection(UTI), run by KEB Nutraceuticals USA, Inc. 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 12 inclusion and 25 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: finished, as of the sponsor's last update on 5 Dec 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between D-mannose and placebo (time frame: Day 1 to 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.