NCT06719115

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: KEB Nutraceuticals USA, Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2023-05-03
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: Canada