Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-28 @ 4:06 PM
Study NCT ID:
NCT00724204
Status:
COMPLETED
Last Update Posted:
2008-07-29
First Post:
2008-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-28', 'studyFirstSubmitDate': '2008-07-28', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': '3 months and 6 months'}], 'secondaryOutcomes': [{'measure': 'growth parameters (height, length, head circumference)', 'timeFrame': '3 months and 6 months'}, {'measure': 'Fecal microbiota', 'timeFrame': '3 months and 6 months'}, {'measure': 'Fecal short chain fatty acids', 'timeFrame': '3 months and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['probiotics', 'safety', 'fecal microbiota', 'infections'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '20018483', 'type': 'DERIVED', 'citation': 'Maldonado J, Lara-Villoslada F, Sierra S, Sempere L, Gomez M, Rodriguez JM, Boza J, Xaus J, Olivares M. Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children. Nutrition. 2010 Nov-Dec;26(11-12):1082-7. doi: 10.1016/j.nut.2009.08.023. Epub 2009 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy six months old children\n\nExclusion Criteria:\n\n* Lactose intolerance\n* Cow's milk protein allergy\n* Serious metabolic diseases\n* Antibiotic treatment\n* Serious gastrointestinal diseases"}, 'identificationModule': {'nctId': 'NCT00724204', 'acronym': 'P010', 'briefTitle': 'Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Puleva Biotech'}, 'officialTitle': 'Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713', 'orgStudyIdInfo': {'id': 'Safety Salivarius'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'Children that consumed a follow on formula without Lactobacillus salivarius CECT5713', 'interventionNames': ['Dietary Supplement: follow on formula without probiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Children that consumed a follow on formula with Lactobacillus salivarius CECT5713', 'interventionNames': ['Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713']}], 'interventions': [{'name': 'follow on formula without probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A follow on formula without probiotics', 'armGroupLabels': ['A']}, {'name': 'follow on formula with Lactobacillus salivarius CECT5713', 'type': 'DIETARY_SUPPLEMENT', 'description': 'follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18012', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'José A Maldonado, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics. Hospital Universitario San Cecilio'}, {'name': 'Mónica Olivares, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Nutrition and Health. Puleva Biotech. Granada'}, {'name': 'Federico Lara-Villoslada, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nutrition and Helath. Puleva Biotech. Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puleva Biotech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Clinico Universitario San Cecilio', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Federico Lara-Villoslada', 'oldOrganization': 'Puelav Biotech'}}}}