To analyze the clinical impact of a food supplement composed of D Mannose, cranberry extract (Cran-max) and Vitamin D3 in the prevention of recurrent lower urinary tract infections (UTI)
Once patients have been informed about the study, the potential risks and treatment alternatives, those who meet the selection criteria, agree to participate and sign the informed consent, will be randomly and openly assigned, in a 1:1:1 ratio, to one of the following groups: Group A: Patients with repeat UTIs who will receive prophylactic treatment for 6 Months. Group B: Patients with repeat UTIs who will receive prophylactic treatment for 3 Months. Control group: Patients with recurrent UTIs who will not receive as prophylactic treatment the supplement under study. The three groups will be treated following standard clinical practice with follow-up at 3, 6, 9 and 12 months after inclusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
108
Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 6 months
Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 3 months
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
UTI Recurrence
Number of patients with recurrences (defined as: number of patients with at least one UTI during the study period) at 6 months.
Time frame: Through study completion, an average of one year
UTI Recurrence
Time (in days) from the start of treatment to the next episode of UTI
Time frame: Variable for each participant over course of up to one year
Number of symptomatic UTIs
Time frame: Variable for each participant over course of up to one year
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