Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280592
• Other study ID #: AFSSAPS 051016
• Secondary ID: PHRC/04-03CIC020
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2006
• Last updated: May 18, 2012
• Start date: January 2006
• Est. completion date: October 2008

Study information

• Verified date: May 2008
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bladder Dysfunction
• Infection
• Multiple Sclerosis
• Sclerosis
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
France	Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz	Besançon
France	Service de Médecine Physique et Réadaptation - Hôpital Pellegrin	Bordeaux
France	Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré	Garches
France	Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré	Garches
France	Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert	Lomme
France	Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild	Paris
France	Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE	Ploemeur
France	Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes	Rennes
France	Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou	Rennes
France	Service de médecine physique et réadapation Hopital de Rangueil	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France, Pierre Fabre Laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to onset of a first UTI within one year of treatment.		one year	No
Secondary	Rate of patients with at least one UTI during the one-year treatment		Determined at M3, M6, M9 and M12	No
Secondary	Number of UTI		Determined at M3, M6, M9 and M12	No
Secondary	Score on Qualiveen® scale		Determined at M3, M6, M9 and M12	No
Secondary	Symptomatology of urinary disorders		Determined at M3, M6, M9 and M12	No
Secondary	EDSS score		Determined at M3, M6, M9 and M12	No
Secondary	Number of multiple sclerosis attacks		Determined at M3, M6, M9 and M12	No
Secondary	Antibiotics consumption		Determined at M3, M6, M9 and M12	No
Secondary	Safety of cranberry		Determined at M3, M6, M9 and M12	Yes
Secondary	Patients' observance to treatment		Determined at M3, M6, M9 and M12	No