Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-21 @ 12:42 AM
Study NCT ID:
NCT00807157
Status:
COMPLETED
Last Update Posted:
2009-04-24
First Post:
2008-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-23', 'studyFirstSubmitDate': '2008-12-08', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SCL 90 questionnaire', 'timeFrame': 'day 0 and day 30'}], 'secondaryOutcomes': [{'measure': 'Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement', 'timeFrame': 'day-14 ; day 0 and day 30'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PROBIOSTICK®', 'Probiotic', 'Anxiety', 'Daily stress'], 'conditions': ['Anxiety', 'Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian healthy men or women\n* Age 30-60 years\n* Hospital anxiety and depression score equal or below 12 and above 4\n* Standard safety biology\n\nExclusion Criteria:\n\n* HAD A results above 12 and below 4\n* HAD D results above 12\n* Neurologic or psychiatric pathology\n* Consumption of psychotropic\n* High level of caffeine consumption\n* Any important chronic pathology\n* Drugs wich impairs concentration, anxiety and stress'}, 'identificationModule': {'nctId': 'NCT00807157', 'acronym': 'BIOSTRESS', 'briefTitle': 'Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Rosell Lallemand'}, 'officialTitle': "Evaluation Des Effets Anti-Stress D'un Probiotique Nomme PROBIOSTICK® Sur Des Sujets Humains Volontaires Sains Sensibles Au Stress De La Vie Quotidienne", 'orgStudyIdInfo': {'id': 'BIOSTRESS 11008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Every morning subjects will consume a stick of placebo during 30 days', 'interventionNames': ['Dietary Supplement: Placebo during 30 days']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Every morning subjects will consume a stick of PROBIOSTICK® during 30 days', 'interventionNames': ['Dietary Supplement: PROBIOSTICK® during 30 days']}], 'interventions': [{'name': 'PROBIOSTICK® during 30 days', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Every morning subjects will consume a stick of PROBIOSTICK® during 30 days', 'armGroupLabels': ['1']}, {'name': 'Placebo during 30 days', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Every morning subjects will consume a stick of placebo during 30 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44200', 'city': 'Nantes', 'country': 'France', 'facility': 'Biofortis', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Rosell Lallemand', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Docteur Jean Marc Cazaubiel', 'oldOrganization': 'Biofortis'}}}}