Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00280592
• Date of registration: 20/01/2006
• Prospective Registration: No
• Primary sponsor: Rennes University Hospital
• Public title: Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients CANNEBERGE
• Scientific 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.
• Date of first enrolment: January 2006
• Target sample size: 171
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00280592
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Philippe Gallien, MD
• Affiliation: CHU Rennes

• Name: Jean-Michel Reymann, PhD
• Affiliation: CHU Rennes

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Urinary Tract Infections

Multiple Sclerosis

Bladder Dysfunction

Intervention(s)

Drug: Placebo

Drug: Cranberry

Primary Outcome(s)

Time to onset of a first UTI within one year of treatment. [Time Frame: one year]

Secondary Outcome(s)

Rate of patients with at least one UTI during the one-year treatment [Time Frame: Determined at M3, M6, M9 and M12]

EDSS score [Time Frame: Determined at M3, M6, M9 and M12]

Score on Qualiveen® scale [Time Frame: Determined at M3, M6, M9 and M12]

Number of multiple sclerosis attacks [Time Frame: Determined at M3, M6, M9 and M12]

Patients' observance to treatment [Time Frame: Determined at M3, M6, M9 and M12]

Symptomatology of urinary disorders [Time Frame: Determined at M3, M6, M9 and M12]

Antibiotics consumption [Time Frame: Determined at M3, M6, M9 and M12]

Number of UTI [Time Frame: Determined at M3, M6, M9 and M12]

Safety of cranberry [Time Frame: Determined at M3, M6, M9 and M12]

Secondary ID(s)

PHRC/04-03

AFSSAPS 051016

CIC0203/039

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pierre Fabre Laboratories

Ministry of Health, France