Urinary Tract Infections
Conditions
Keywords
D-mannose
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.
Interventions
DRUGMannose
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
DRUGLactose
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
Sponsors
Kantonsspital Aarau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| During UTI: Urgency | during every UTI in the 6 months period | 4 categories: no, mild, moderate, severe |
| During UTI: Frequency | 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: 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 |
| During UTI: Flank (side) pain | during every UTI in the 6 months period | 4 categories: no, mild, moderate, severe |
Other
| Measure | Time frame | Description |
|---|---|---|
| Birth control | at the screening | 2 categories: yes, no |
| Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified | at the screening and during every UTI in the 6 months period | 2 categories: yes, no |
| Number of CFU | at the screening and during every UTI in the 6 months period | number |
| Weight | at the screening | in kilograms |
| Height | at the screening | in cm |
| Menopause status | at the screening | 3 categories: premenopausal, perimenopausal, postmenopausal |
| Sexual activity | at the screening | 2 categories: yes, no |
| Medication | at the screening and during every UTI in the 6 months period | 2 categories: yes, no if yes: Name of the medication, dosage, reason for medication, start and end date of medication |
| Age | at the screening | in years |
Countries
Switzerland
Outcome results
None listed