Clinical trial NCT00280592: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Urinary Tract Infections
Bladder Dysfunction
Keywords: Prophylaxis
Cranberry
Neurogenic bladder
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Laboratories
name: Ministry of Health, France
First posted: 2006-01-23
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to onset of a first UTI within one year of treatment.
timeFrame: one year
Secondary outcomes:
measure: Rate of patients with at least one UTI during the one-year treatment
timeFrame: Determined at M3, M6, M9 and M12
measure: Number of UTI
timeFrame: Determined at M3, M6, M9 and M12
measure: Score on Qualiveen® scale
timeFrame: Determined at M3, M6, M9 and M12
measure: Symptomatology of urinary disorders
timeFrame: Determined at M3, M6, M9 and M12
measure: EDSS score
timeFrame: Determined at M3, M6, M9 and M12
measure: Number of multiple sclerosis attacks
timeFrame: Determined at M3, M6, M9 and M12
measure: Antibiotics consumption
timeFrame: Determined at M3, M6, M9 and M12
measure: Safety of cranberry
timeFrame: Determined at M3, M6, M9 and M12
measure: Patients' observance to treatment
timeFrame: Determined at M3, M6, M9 and M12
Other outcomes:
Locations:
city: Besançon
country: France
facility: Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
city: Bordeaux
country: France
facility: Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
city: Garches
country: France
facility: Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
city: Garches
country: France
facility: Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré
city: Lomme
country: France
facility: Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert
city: Paris
country: France
facility: Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild
city: Ploemeur
country: France
facility: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
city: Rennes
country: France
facility: Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
city: Rennes
country: France
facility: Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes
city: Toulouse
country: France
facility: Service de médecine physique et réadapation Hopital de Rangueil
Study officials:
affiliation: CHU Rennes
name: Jean-Michel Reymann, PhD
role: STUDY_CHAIR
affiliation: CHU Rennes
name: Philippe Gallien, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallien P, Amarenco G, Benoit N, Bonniaud V, Donze C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.