Preventing Recurrent Urinary Tract Infections With α-D-mannose

Phase 4TerminatedNCT03497598

Kantonsspital Aarau15 enrolled

Overview

In this trial, women with history of recurrent urinary tract infections (UTIs) will be followed over the course of 6 months. The women will be randomized either to D- Mannose or Placebo. The primary objective of this study is to investigate if treatment with D-mannose reduces the risk for a UTI recurrence compared to treatment with Placebo. H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same number of recurrent UTIs over the course of 6 months compared to women treated with Placebo. H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer recurrent UTIs over the course of 6 months compared to women treated with Placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Urinary Tract Infections

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women * ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months; * Laboratory urine culture: \<103 CFUs * Age \> 18 years Exclusion Criteria: * UTIs ≥ 12 within 1 year * Pregnancy or Lactation * Immune disease * Lactose intolerance * Urinary tract anomaly * Systemic infection * Newly started hormone therapy within the last 6 months * Antibiotic prophylaxis within the last 6 months * α-D-mannose intake within the last month * Use of catheters * Diabetes mellitus * Participation to other studies

Outcomes

Primary Outcomes

Frequency of UTIs

Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.

Time frame: 6 months