Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

NCT ID: NCT00280592

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-10-31

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.

Conditions

Multiple Sclerosis; Urinary Tract Infections; Bladder Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Cranberry

Cranberry

Group Type: EXPERIMENTAL

Cranberry

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Vaccinium macrocarpon

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Laboratories

INDUSTRY

Sponsor Role: collaborator

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Michel Reymann, PhD

Role: STUDY_CHAIR

CHU Rennes

Philippe Gallien, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz

Besançon, , France

Service de Médecine Physique et Réadaptation - Hôpital Pellegrin

Bordeaux, , France

Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré

Garches, , France

Consultations maladies infectieuses et tropicales, 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

Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

Rennes, , France

Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes

Rennes, , France

Service de médecine physique et réadapation Hopital de Rangueil

Toulouse, , France

Countries

France

References

Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

Reference Type: DERIVED

PMID: 37947276 (View on PubMed)

Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

Reference Type: DERIVED

PMID: 37068952 (View on PubMed)

Gallien P, Amarenco G, Benoit N, Bonniaud V, Donze C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.

Reference Type: DERIVED

PMID: 24402038 (View on PubMed)

Other Identifiers

PHRC/04-03

Identifier Type: OTHER

Identifier Source: secondary_id

CIC0203/039

Identifier Type: -

Identifier Source: secondary_id

AFSSAPS 051016

Identifier Type: -

Identifier Source: org_study_id