Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
Study NCT ID:
NCT04441359
Status:
COMPLETED
Last Update Posted:
2020-06-22
First Post:
2020-06-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2010-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infections during first year of life', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'measured through presence of fever, and number and duration of infectious episodes'}], 'secondaryOutcomes': [{'measure': 'Stool frequency', 'timeFrame': 'until infant reaches age of 1 year', 'description': "Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)"}, {'measure': 'Stool consistency', 'timeFrame': 'until infant reaches age of 1 year', 'description': "Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)"}, {'measure': 'Digestive tolerance', 'timeFrame': 'until infant reaches age of 1 year', 'description': "Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)"}, {'measure': 'Growth', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software).'}, {'measure': 'Body weight', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits.'}, {'measure': 'Body height', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'Assessment of height (cm) in supine position by using a standard measuring board at all study visits.'}, {'measure': 'Head circumference', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.'}, {'measure': 'Sleeping habits', 'timeFrame': 'until infant reaches age of 1 year', 'description': "Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)."}, {'measure': 'Crying episodes', 'timeFrame': 'until infant reaches age of 1 year', 'description': "Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)."}, {'measure': 'Effect on fecal microbiota composition', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'Quantification of dominant bacterial groups'}, {'measure': 'Effect on development of allergy', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema'}, {'measure': 'Effect on immunology markers in feces', 'timeFrame': 'until infant reaches age of 1 year', 'description': 'secretory immunoglobulin A, calprotectin level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection', 'Microbial Colonization', 'Healthy']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.', 'detailedDescription': 'The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)\n* Healthy babies aged between 0 - 4 months of age\n* Babies exclusively fed with an infant formula on enrolment into the study\n\nExclusion Criteria:\n\n* The presence of an infection at the moment of the recruitment or 1 week before recruitment\n* The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)\n* Any other diseases related to the immune system (primary immunodeficiency)\n* Parents not able to comply with the study follow up (according to physician criteria)'}, 'identificationModule': {'nctId': 'NCT04441359', 'briefTitle': 'Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beneo-Institute'}, 'officialTitle': 'Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants', 'orgStudyIdInfo': {'id': 'Study protocol June 2008 final'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'supplemented formula', 'description': 'Standard formula supplemented with prebiotic inulin-type fructans', 'interventionNames': ['Other: Supplemented formula']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'standard formula', 'description': 'Standard Formula not supplemented with prebiotic inulin-type fructans', 'interventionNames': ['Other: Standard formula']}], 'interventions': [{'name': 'Supplemented formula', 'type': 'OTHER', 'description': 'standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans', 'armGroupLabels': ['supplemented formula']}, {'name': 'Standard formula', 'type': 'OTHER', 'description': 'standard infant formula not supplemented with prebiotic inulin-type fructans', 'armGroupLabels': ['standard formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Koningin Paola Kinderziekenhuis', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'CAP Llefià', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Nens', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "University Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Equipo Pediátrico San Francisco', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beneo-Institute', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Laboratorios Ordesa', 'class': 'INDUSTRY'}, {'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}