Preventing Recurrent Urinary Tract Infections With α-D-mannose (PUTIM)

Kantonsspital Aarau

Status and phase: Terminated; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Mannose; Drug: Lactose

Study type: Interventional

Funder types: Other

Identifiers

NCT03497598

PUTIM

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

mannose

Experimental group

Description:

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

Treatment:

Drug: Mannose

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Lactose