A Clinical Trial to Investigate the Safety and Efficacy of D-Mannose on Symptoms of Urinary Tract Infection in Women

NCT06719115 | Completed Phase 2

• 1 other identifier: 22KBCFD01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is there a difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between UClear and placebo
2. 2.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.

Conditions

Urinary Tract Infection(UTI)

Keywords

Uncomplicated urinary tract infection

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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

  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

  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

  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

  Day 1 to 4

Secondary Outcomes (14)

• The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo

  Day 1 to 2

• The difference in proportion of participants with complete resolution of UTI symptoms between D-mannose and placebo

  Day 1 to 3

• The difference in the change in symptom severity scores from baseline between D-mannose and placebo

  Day 1 to 2

• The difference in the change in symptom severity scores from baseline between D-mannose and placebo

  Day 1 to 3

• The difference in the change in UTISA bother scores from baseline between D-mannose and placebo

  Day 1 to 2

Other Outcomes (5)

• Incidence of pre-emergent and post-emergent adverse events (AE)

  Day 1 to 7

• Incidence of clinically relevant changes in blood pressure (BP)

  Day 1 to 4

• Incidence of clinically relevant changes in heart rate (HR)

  Day 1 to 4

Study Arms (2)

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.

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.

Other: Placebo

Interventions

UClear DIETARY_SUPPLEMENT

Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).

UClear

Placebo OTHER

Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• KEB Nutraceuticals USA, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

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

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: May 3, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)