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

May 18, 2012 updated by: Rennes University Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
      • Bordeaux, France, 33076
        • Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
      • Garches, France, 92380
        • Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
      • Garches, France
        • Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré
      • Lomme, France, 59160
        • Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert
      • Paris, France, 75571
        • Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild
      • Ploemeur, France, 56275
        • Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
      • Rennes, France, 35033
        • Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
      • Rennes, France, 35043
        • Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes
      • Toulouse, France, 31059
        • Service de médecine physique et réadapation Hopital de Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • Vaccinium macrocarpon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to onset of a first UTI within one year of treatment.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with at least one UTI during the one-year treatment
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
Number of UTI
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
Score on Qualiveen® scale
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
Symptomatology of urinary disorders
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
EDSS score
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
Number of multiple sclerosis attacks
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
Antibiotics consumption
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
Safety of cranberry
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12
Patients' observance to treatment
Time Frame: Determined at M3, M6, M9 and M12
Determined at M3, M6, M9 and M12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France
Pierre Fabre Laboratories

Investigators

  • Principal Investigator: Philippe Gallien, MD, CHU Rennes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSSAPS 051016
  • PHRC/04-03 (Other Identifier: Rennes University Hospital)
  • CIC0203/039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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