Multiple Sclerosis Clinical Trial
Official title:
Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.
Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.
Bladder dysfunction occurs at some time in 70 to 90% of patients with multiple sclerosis and
these patients are prone to have recurrent urinary tract infections (UTI), leading to an
important morbidity. Cranberry has been traditionally used for the treatment and prevention
of UTI and research suggests that its mechanism of action is preventing bacterial adherence
to host cell surface membrane.
However, systematic reviews show the small sample sizes and the poor quality of available
trials, determining that there is no reliable evidence of effectiveness of cranberry in UTI
prophylaxis. Therefore, to assess whether cranberry is effective in reducing UTI in patients
with multiple sclerosis, we have designed a randomized, double-blind, placebo-controlled
trial. Efficacy will be evaluated on the time to onset of a UTI in the first year of
treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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