Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT01215656
Status:
COMPLETED
Last Update Posted:
2010-10-07
First Post:
2010-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'lastUpdateSubmitDate': '2010-10-06', 'studyFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infectious diseases'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Incidence of Infectious Diseases']}, 'referencesModule': {'references': [{'pmid': '21873895', 'type': 'DERIVED', 'citation': 'Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 6 months old children born at term\n* written consent from parents\n\nExclusion Criteria:\n\n* frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)\n* gastrointestinal surgery\n* cow's milk protein allergy\n* metabolic diseases (diabetes or lactose intolerance)\n* immune deficiency\n* antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)"}, 'identificationModule': {'nctId': 'NCT01215656', 'briefTitle': 'Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Puleva Biotech'}, 'orgStudyIdInfo': {'id': 'L. fermentum infections'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'follow on formula with the probiotic Lactobacillus fermentum', 'interventionNames': ['Dietary Supplement: Lactobacillus fermentum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'follow on formula without probiotics', 'interventionNames': ['Dietary Supplement: Follow on formula without probiotics']}], 'interventions': [{'name': 'Lactobacillus fermentum', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Probiotic']}, {'name': 'Follow on formula without probiotics', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puleva Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Federico Lara Villoslada', 'oldOrganization': 'Puleva Biotech'}}}}