Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
Study NCT ID:
NCT00753961
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2008-09-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect Of The Consumption Of Fermented Dairy Drink On Common Infections In Shift-Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D043302', 'term': 'Cultured Milk Products'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2008-09-16', 'studyFirstSubmitQcDate': '2008-09-16', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of common infectious diseases during the 16 weeks of study product consumption', 'timeFrame': '0-16 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean duration of common infectious diseases during the 16 weeks of study product consumption.', 'timeFrame': '0-16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shiftworkers', 'volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This clinical study plans to investigate the effect of the consumption of a fermented dairy drink on the occurrence of common infections. This study will be performed in a healthy adult population of shift workers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female subjects aged 18 to 65 years (bounds included)\n* Healthy subjects.\n* Subjects working in two- or three-shift work including night work\n\nExclusion Criteria:\n\n* Subject with any food allergy\n* Subject in a situation that, in the investigator opinion, could interfere with optimal participation in the present study or could constitute a special risk for the subject.'}, 'identificationModule': {'nctId': 'NCT00753961', 'briefTitle': 'Effect Of The Consumption Of Fermented Dairy Drink On Common Infections In Shift-Workers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Global Research & Innovation Center'}, 'officialTitle': 'EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS', 'orgStudyIdInfo': {'id': 'NU289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'fermented dairy product', 'interventionNames': ['Other: fermented dairy product']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'non fermented acidified dairy product.', 'interventionNames': ['Other: non fermented dairy product']}], 'interventions': [{'name': 'fermented dairy product', 'type': 'OTHER', 'description': 'fermented dairy product (2 bottles/day during 16 weeks)', 'armGroupLabels': ['1']}, {'name': 'non fermented dairy product', 'type': 'OTHER', 'description': 'non fermented dairy product (2 bottles/day during 16 weeks)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Caen', 'country': 'France', 'facility': 'Therapharm', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'VEEDA', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}