Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00948051
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2009-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C116580', 'term': 'fructooligosaccharide'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-12', 'studyFirstSubmitDate': '2009-07-27', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination", 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': "To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration", 'timeFrame': '1 month'}]}, 'conditionsModule': {'conditions': ['Infant']}, 'descriptionModule': {'briefSummary': 'In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Months', 'minimumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants aged of 4 months at randomization\n* not breast-fed infants\n\nExclusion Criteria:\n\n* infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria\n* infants suffering from a disease associated with gastro-intestinal disorder\n* infants who have taken antibiotic during the 2 months preceding randomization'}, 'identificationModule': {'nctId': 'NCT00948051', 'briefTitle': 'Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syral'}, 'officialTitle': 'A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants', 'orgStudyIdInfo': {'id': 'FOS_FOF08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fructo-oligosaccharides', 'interventionNames': ['Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)']}], 'interventions': [{'name': 'Follow-on formula supplemented with fructo-oligosaccharides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Follow-on formula supplemented with fructo-oligosaccharides', 'armGroupLabels': ['Fructo-oligosaccharides']}, {'name': 'Follow-on formula enriched with placebo (maltodextrins)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Follow-on formula enriched with placebo (maltodextrins)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Dr Tormo', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syral', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Frederique Respondek/ Scientific Affairs Manager', 'oldOrganization': 'Syral'}}}}