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| Descriptive Information Fields | |||||||||
| Brief Title † | Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients | ||||||||
| 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. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Time to onset of a first UTI within one year of treatment. [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Rate of patients with at least one UTI during the one-year treatment [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] Number of UTI [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] Score on Qualiveen® scale [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] Symptomatology of urinary disorders [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] EDSS score [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] Number of multiple sclerosis attacks [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] Antibiotics consumption [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] Safety of cranberry [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: Yes ] Patients' observance to treatment [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ] |
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| Condition † | Multiple Sclerosis Urinary Tract Infections Bladder Dysfunction |
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| Intervention † | Drug: Cranberry Drug: Placebo |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 290 | ||||||||
| Start Date † | January 2006 | ||||||||
| Completion Date | June 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | France | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00280592 | ||||||||
| Organization ID | AFSSAPS 051016 | ||||||||
| Secondary IDs †† | PHRC/04-03, CIC0203/039 | ||||||||
| Study Sponsor † | Rennes University Hospital | ||||||||
| Collaborators †† | Pierre Fabre Laboratories Ministry of Health, France |
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| Investigators † |
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| Information Provided By | Rennes University Hospital | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | January 20, 2006 | ||||||||
| Last Updated Date | May 21, 2008 | ||||||||
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