Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT00796393
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2008-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2008-11-21', 'studyFirstSubmitQcDate': '2008-11-21', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of infectious episodes', 'timeFrame': 'During the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)']}, 'descriptionModule': {'briefSummary': 'We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who accept not to alter their food habits\n\nExclusion Criteria:\n\n* Food allergy\n* Regular consumption of probiotics\n* Diabetes\n* Respiratory deficiency\n* Cardiac deficiency\n* Cancer or chronicle disease not stabilized\n* Splenectomy, sickle-cell anemia\n* Immuno depression or immunodeficiency acquired or congenital\n* Immuno depressor or corticoid treatments'}, 'identificationModule': {'nctId': 'NCT00796393', 'briefTitle': 'Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Rosell Lallemand'}, 'officialTitle': 'Effects of Daily Consumption of a Probiotic on the Evolution of Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), in Subject Aged 60 Years or Over, During Winter.', 'orgStudyIdInfo': {'id': '10308'}, 'secondaryIdInfos': [{'id': '2008-A01187-48'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Subject with active product, not vaccinated against influenza.', 'interventionNames': ['Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Subject with placebo, vaccinated against influenza.', 'interventionNames': ['Dietary Supplement: Starch of potato']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Subject with placebo, not vaccinated against influenza.', 'interventionNames': ['Dietary Supplement: Starch of potato']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Subject with active product, vaccinated against influenza', 'interventionNames': ['Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033']}], 'interventions': [{'name': 'Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 pill per day for 12 weeks', 'armGroupLabels': ['1', '2']}, {'name': 'Starch of potato', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 pill per day for 12 weeks', 'armGroupLabels': ['3', '4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'Biofortis', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Jean Marc Cazaubiel, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioFortis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Rosell Lallemand', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioFortis', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Henri Durand', 'oldOrganization': 'Institut Rosell Lallemand'}}}}