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

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00280592

Collaborator

Pierre Fabre Laboratories (Industry), Ministry of Health, France (Other)

171

Enrollment

Locations

Arms

Duration (Months)

17.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Urinary Tract Infections Bladder Dysfunction	Drug: Cranberry Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

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 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

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz	Besançon	France	25030
2	Service de Médecine Physique et Réadaptation - Hôpital Pellegrin	Bordeaux	France	33076
3	Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré	Garches	France	92380
4	Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré	Garches	France
5	Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert	Lomme	France	59160
6	Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild	Paris	France	75571
7	Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE	Ploemeur	France	56275
8	Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou	Rennes	France	35033
9	Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes	Rennes	France	35043
10	Service de médecine physique et réadapation Hopital de Rangueil	Toulouse	France	31059