None listed
Conditions
Brief summary
D-mannose is a carbohydrate and important in the metabolism of some proteins within the human body. It has been shown to prevent the adherence of E-coli bacteria to the uroepithelial lining found in the bladder. This is important because E coli is the most common pathogen responsible for urinary tract infections. D-mannose has also been shown to be useful in reducing the bacteriuria (bacteria in the urine) in animal studies and is used in equine veterinarian practices for this purpose. Previous studies using D-mannose as a preventative measure against UTI have been promising. However, none have examined the effect in patients with diabetes mellitus or the elderly patient, who frequently have recurrent and resistant strains of E-coli in their urine. Therefore the aim of this study is to measure the effectiveness of D-Mannose in reducing the development of full urinary tract infection in those high risk patients who experience recurrent urinary tract infection. The study will be a double blind randomised trial with the primary outcome examining the percentage of patients developing a UTI during the study period. It will be conducted over a 24 week period.
Interventions
The intervention is single dose of 2.5 grams of D-Mannose will be dissolved in water and drank every evening for 24 weeks.
Compliance: The allocated container holding the intervention will be weighed before being given to participants. Participants will be asked to return for six further follow-up appointments (one per month) with the research nurse and bring the same container with them. The container will be reweighed and documented. Comparison to baseline weight will be performed and estimate
The intervention is single dose of 2.5 grams of D-Mannose will be dissolved in water and drank every evening for 24 weeks. Compliance: The allocated container holding the intervention will be weighed before being given to participants. Participants will be asked to return for six further follow-up appointments (one per month) with the research nurse and bring the same container with them. The container will be reweighed and documented. Comparison to baseline weight will be performed and estimate of dose taken in grams for monthly period will be calculated.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Female Aged over 60 years Diagnosed with diabetes mellitus Adequate renal function as determined by treating medical officer Diagnosed with recurrent UTI defined as 2 or more infections in 6 months or 3 or more infections in 12 months Currently free of UTI (determined by absence of clinical symptoms) Able to give valid consent Available to attend a maximum of eight appointments at Sir Charles Gairdner Hospital.
Exclusion criteria
Current UTI or receiving treatment for UTI Unable to give valid consent Heavily dependent on medical care Multiple co-morbidities (co-morbidities greater than 3 as determined by the Charlston Index) Unable to attend appointments Unable to read / write English Unable to comply with study protocol
Outcome results
None listed