Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients - Full Text View

Sponsors and Collaborators:	Rennes University Hospital Pierre Fabre Laboratories Ministry of Health, France
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00280592

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis Urinary Tract Infections Bladder Dysfunction	Drug: Cranberry Drug: Placebo	Phase III

MedlinePlus related topics: Multiple Sclerosis Urinary Tract Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

Time to onset of a first UTI within one year of treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	290
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator	Drug: Placebo Placebo presented as sachets of powder. Placebo juice is administered twice a day.
1: Experimental Cranberry	Drug: Cranberry Dry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day.

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Exclusion Criteria:

Regular consumption of cranberry within 3 months before inclusion
Symptomatic urinary tract infection at inclusion
Chronic renal failure (creatininemia < 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280592

Locations

France
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Rennes, France, 35033
Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes
Rennes, France, 35043
Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
Besançon, France, 25030
Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
Bordeaux, France, 33076
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
Ploemeur, France, 56275
Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert
Lomme, France, 59160
Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild
Paris, France, 75571
Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
Garches, France, 92380

Sponsors and Collaborators

Rennes University Hospital

Pierre Fabre Laboratories

Ministry of Health, France

Investigators

Study Chair:	Jean-Michel Reymann, PhD	CHU Rennes
Principal Investigator:	Philippe Gallien, MD	CHU Rennes

More Information

No publications provided

Responsible Party:	Rennes University Hospital ( Direction of Clinical Research and Strategy )
Study ID Numbers:	AFSSAPS 051016, PHRC/04-03, CIC0203/039
Study First Received:	January 20, 2006
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00280592 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:

Prophylaxis
Cranberry
Neurogenic bladder

Study placed in the following topic categories:

Urinary Bladder, Neurogenic
Autoimmune Diseases
Multiple Sclerosis
Urologic Diseases
Demyelinating Diseases

Urinary Tract Infections
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Communicable Diseases
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Urinary Tract Infections
Nervous System Diseases
Sclerosis

Infection
Multiple Sclerosis
Pathologic Processes
Urologic Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009