Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT01315418
Status:
TERMINATED
Last Update Posted:
2016-11-25
First Post:
2011-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D009304', 'term': 'Nasopharyngitis'}, {'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2011-03-14', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotic - Lactobacillus casei DN-114 001 - dairy product -', 'infections - firemen', 'Common infectious diseases, occuring in healthy subjects,', 'including upper respiratory tract infections (defined as', 'rhinopharyngitis, sore throat, sinusitis and otitis)', 'lower respiratory tract infections (defined as bronchitis', 'pneumopathy and flu and flu-like syndromes)', 'gastrointestinal tract infection defined as gastroenteritis'], 'conditions': ['Upper Respiratory Tract Infections', 'Rhinopharyngitis', 'Sore Throat', 'Sinusitis', 'Otitis', 'Lower Respiratory Tract Infections', 'Bronchitis', 'Pneumopathy', 'Flu', 'Flu-like Syndromes', 'Gastroenteritis']}, 'descriptionModule': {'briefSummary': 'This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male and female aged 18-29 years\n* attending 7 weeks of firemen training school\n* a 19 to 29 kg/m2 body mass index\n* found medically healthy (in particular, free of respiratory and GI tract symptoms)\n* agreeing to a written informed consent, and who appreciates dairy products and multi-fruit flavour.\n\nExclusion Criteria:\n\n* Subject who is not reading and writing French, or not understanding informed consent or study protocol\n* subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose), or with any known food or respiratory allergy;\n* subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes…) or any past or actual health condition that may interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease…)\n* subject having experienced any infectious disease during the last 7 days\n* subject with current diarrhoea or constipation\n* subject who is frequently using laxatives or who has been using laxatives during the week prior his participation to the study\n* subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study\n* subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation…) or with eating disorders (anorexia, bulimia, alcoholism…)\n* subject currently receiving, or who has received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics,antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid anti-inflammatory substances, immunosuppressant treatment…\n* subject already enrolled in another clinical study, or currently under an exemption period from a previous study\n* female subject who is currently pregnant or breast-feeding, or willing to become pregnant during the 2 coming months after enrolment in the study\n* subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject"}, 'identificationModule': {'nctId': 'NCT01315418', 'briefTitle': 'Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Global Research & Innovation Center'}, 'officialTitle': 'Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation', 'orgStudyIdInfo': {'id': 'NU201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 = Tested product', 'interventionNames': ['Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)']}, {'type': 'SHAM_COMPARATOR', 'label': '2 = Control product', 'interventionNames': ['Other: 2-Non fermented dairy product (control)']}], 'interventions': [{'name': '1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)', 'type': 'OTHER', 'armGroupLabels': ['1 = Tested product']}, {'name': '2-Non fermented dairy product (control)', 'type': 'OTHER', 'armGroupLabels': ['2 = Control product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94190', 'city': 'Villeneuve-Saint-Georges', 'country': 'France', 'facility': 'Médecin-chef du Groupement Formation Instruction', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}