Preventing Recurrent Urinary Tract Infections With α-D-mannose

Phase 4

Terminated

• Conditions: Urinary Tract Infections
• Interventions: Drug: Mannose; Drug: Lactose

• Registration Number: NCT03497598
• Lead Sponsor: Kantonsspital Aarau

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-13
• Study Start: 2018-05-09
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mannose	Mannose	2g d-mannose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months.The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary
placebo	Lactose	2g Hänseler lactose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months. The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
During UTI: Frequency	during every UTI in the 6 months period	4 categories: no, mild, moderate, severe
During UTI: Flank (side) pain	during every UTI in the 6 months period	4 categories: no, mild, moderate, severe
During UTI: Dysuria	during every UTI in the 6 months period	4 categories: no, mild, moderate, severe
During UTI: Urgency	during every UTI in the 6 months period	4 categories: no, mild, moderate, severe
During UTI: Cystalgia	during every UTI in the 6 months period	4 categories: no, mild, moderate, severe
During UTI: Back pain	during every UTI in the 6 months period	4 categories: no, mild, moderate, severe

Trial Locations

Locations (1)

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland