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

Primary Purpose

Multiple Sclerosis, Urinary Tract Infections, Bladder Dysfunction

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Cranberry

Placebo

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Prophylaxis, Cranberry, Neurogenic bladder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré
Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert
Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes
Service de médecine physique et réadapation Hopital de Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Cranberry

Arm Description

Cranberry

Outcomes

Primary Outcome Measures

Time to onset of a first UTI within one year of treatment.

Secondary Outcome Measures

Rate of patients with at least one UTI during the one-year treatment

Number of UTI

Score on Qualiveen® scale

Symptomatology of urinary disorders

EDSS score

Number of multiple sclerosis attacks

Antibiotics consumption

Safety of cranberry

Patients' observance to treatment

Full Information

NCT ID

NCT00280592

First Posted

January 20, 2006

Last Updated

May 18, 2012

Sponsor

Rennes University Hospital

Collaborators

Pierre Fabre Laboratories, Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT00280592

Brief Title

Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

Acronym

CANNEBERGE

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

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

Collaborators

Pierre Fabre Laboratories, Ministry of Health, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Urinary Tract Infections, Bladder Dysfunction

Keywords

Prophylaxis, Cranberry, Neurogenic bladder

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

171 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Cranberry

Arm Type

Experimental

Arm Description

Cranberry

Intervention Type

Drug

Intervention Name(s)

Cranberry

Other Intervention Name(s)

Vaccinium macrocarpon

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).

Primary Outcome Measure Information:

Title

Time to onset of a first UTI within one year of treatment.

Time Frame

one year

Secondary Outcome Measure Information:

Title

Rate of patients with at least one UTI during the one-year treatment

Time Frame