Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-07 @ 7:24 AM
Study NCT ID:
NCT00280592
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2006-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-18', 'studyFirstSubmitDate': '2006-01-20', 'studyFirstSubmitQcDate': '2006-01-20', 'lastUpdatePostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to onset of a first UTI within one year of treatment.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Rate of patients with at least one UTI during the one-year treatment', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': 'Number of UTI', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': 'Score on Qualiveen® scale', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': 'Symptomatology of urinary disorders', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': 'EDSS score', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': 'Number of multiple sclerosis attacks', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': 'Antibiotics consumption', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': 'Safety of cranberry', 'timeFrame': 'Determined at M3, M6, M9 and M12'}, {'measure': "Patients' observance to treatment", 'timeFrame': 'Determined at M3, M6, M9 and M12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prophylaxis', 'Cranberry', 'Neurogenic bladder'], 'conditions': ['Multiple Sclerosis', 'Urinary Tract Infections', 'Bladder Dysfunction']}, 'referencesModule': {'references': [{'pmid': '37947276', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37068952', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24402038', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months\n* With an EDSS score ≥ 3\n* Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not\n* Ambulatory at inclusion\n* Able to undergo evaluation\n* Informed written consent\n\nNon-inclusion Criteria:\n\n* Regular consumption of cranberry within 3 months before inclusion\n* Symptomatic urinary tract infection at inclusion\n* Chronic renal failure (creatinin clearance \\< 10ml/min)\n* Patients with urinary permanent catheterization\n* Patients with hyperuricemia and risk of uric acid lithiasis\n* Patients with oral anticoagulant treatment (antivitamins K)\n* Peptic ulcer\n* Intolerance to cranberry and/or excipients\n* Urinary tract infections antibioprophylaxis'}, 'identificationModule': {'nctId': 'NCT00280592', 'acronym': 'CANNEBERGE', 'briefTitle': 'Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'AFSSAPS 051016'}, 'secondaryIdInfos': [{'id': 'PHRC/04-03', 'type': 'OTHER', 'domain': 'Rennes University Hospital'}, {'id': 'CIC0203/039'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cranberry', 'description': 'Cranberry', 'interventionNames': ['Drug: Cranberry']}], 'interventions': [{'name': 'Cranberry', 'type': 'DRUG', 'otherNames': ['Vaccinium macrocarpon'], '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).', 'armGroupLabels': ['Cranberry']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Service de Médecine Physique et Réadaptation - Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'city': 'Garches', 'country': 'France', 'facility': 'Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '59160', 'city': 'Lomme', 'country': 'France', 'facility': "Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert", 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '56275', 'city': 'Ploemeur', 'country': 'France', 'facility': 'Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE', 'geoPoint': {'lat': 47.73512, 'lon': -3.42952}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35043', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Service de médecine physique et réadapation Hopital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jean-Michel Reymann, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Rennes'}, {'name': 'Philippe Gallien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rennes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pierre Fabre Laboratories', 'class': 'INDUSTRY'}, {'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}