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

This study has been completed.
Sponsor:
Collaborators:
Pierre Fabre Laboratories
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00280592
First received: January 20, 2006
Last updated: May 18, 2012
Last verified: May 2008
  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 3

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
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.

Resource links provided by NLM:


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 ]

Enrollment: 171
Study Start Date: January 2006
Study Completion Date: October 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).
Experimental: Cranberry
Cranberry
Drug: Cranberry
Dry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day (in the morning and in the evening).
Other Name: Vaccinium macrocarpon

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

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

Locations
France
Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
Besançon, France, 25030
Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
Bordeaux, France, 33076
Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré
Garches, France
Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
Garches, France, 92380
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
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
Ploemeur, France, 56275
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Rennes, France, 35033
Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes
Rennes, France, 35043
Service de médecine physique et réadapation Hopital de Rangueil
Toulouse, France, 31059
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
ClinicalTrials.gov Identifier: NCT00280592     History of Changes
Other Study ID Numbers: AFSSAPS 051016, PHRC/04-03, CIC0203/039
Study First Received: January 20, 2006
Last Updated: May 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Prophylaxis
Cranberry
Neurogenic bladder

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Urinary Tract Infections
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014