Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients (CANNEBERGE)

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infections; Multiple Sclerosis; Bladder Dysfunction

Treatments: Drug: Cranberry; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00280592

CIC0203/039

AFSSAPS 051016

PHRC/04-03 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months
• With an EDSS score ≥ 3
• Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not
• Ambulatory at inclusion
• Able to undergo evaluation
• Informed written consent

Non-inclusion Criteria:

• Regular consumption of cranberry within 3 months before inclusion
• Symptomatic urinary tract infection at inclusion
• Chronic renal failure (creatinin clearance < 10ml/min)
• Patients with urinary permanent catheterization
• Patients with hyperuricemia and risk of uric acid lithiasis
• Patients with oral anticoagulant treatment (antivitamins K)
• Peptic ulcer
• Intolerance to cranberry and/or excipients
• Urinary tract infections antibioprophylaxis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Cranberry

Experimental group

Description:

Cranberry

Treatment:

Drug: Cranberry