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

NCT06719115 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-05

No results posted yet for this study

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

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)

Interventions

DIETARY_SUPPLEMENT

UClear

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

OTHER

Placebo

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

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • KEB Nutraceuticals USA, Inc.

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2024-06-20
Completion
2024-06-20

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719115 on ClinicalTrials.gov