Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-05 @ 9:49 AM
Study NCT ID:
NCT02096302
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-21', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in diarrhea incidence', 'timeFrame': 'At 4th, 8th, 12th weeks', 'description': 'Differences between diarrhea incidence amongst groups from baseline to 12th weeks.'}], 'secondaryOutcomes': [{'measure': 'Changes in infections incidence', 'timeFrame': 'At 4th, 8th, 12th weeks.', 'description': 'Differences between rate of infections or duration amongst groups.'}, {'measure': 'Changes in microbiota', 'timeFrame': 'At 4th, 8th, 12th weeks', 'description': 'Differences between faecal bacterial populations.'}, {'measure': 'Changes in Immunoglobulin A secretor (IgAs)', 'timeFrame': 'At 4th and 12th weeks', 'description': 'Differences between faecal IgAs amongst groups.'}, {'measure': 'Tolerability of the product', 'timeFrame': 'At 4th, 8th and 12th weeks', 'description': 'To evaluate gastrointestinal tolerability of both study formulas.'}, {'measure': 'Growth', 'timeFrame': 'At 4th, 8th and 12th weeks', 'description': 'To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Probiotics', 'Infant Formula', 'Microbiota', 'Bifidobacterium longum biovar infantis CECT7210', 'Growth'], 'conditions': ['Gastrointestinal Diseases']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Closa R, Ferré N, Luque V, Gispert-Llaurado M, Ruibio-Torrents C, Polanco I, Morera M, Moreno JA, Rivero M, Escribano J. Effect of probiotic CECT7210 supplementation of infant formula in healthy infants. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PA-N-0038.'}, {'type': 'RESULT', 'citation': 'Moreno JA, Cifuentes GC, Morera M, Martínez-Blach JF, Codoñer F, Genovés S, Chenoll E, Polanco I, Closa R, Escribano J, Ferré N, Luque V, Rivero M. Feeding infant formula supplemented with the probiotic bacteria bifidobacterium longum subsp.infantis CECT7210 produce beneficial changes in gastointestinal microbial communities: a metagenomic approach. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PO-N-0361.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.', 'detailedDescription': 'This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Full-term healthy newborns (\\>= 37 weeks)\n* Birth weight between \\>=2.500g and \\<=4.500g)\n* Normal growth curve (between 3-97 percentiles)\n* 0-60 days of age on enrolment\n* Maximum 30 days of breastfeeding\n* Exclusively infant formula on enrolment\n* Breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment\n* Parents or caregivers agree to exclude any source of prebiotics or probiotics during the study\n* Parents or caregivers agree to follow-on the study 12 weeks\n* Informed consent signed ( Parent/Legal representative)\n\nExclusion Criteria:\n\n* Congenital illness or malformation that may affect infant feeding and /or normal growth\n* Significant pre-natal or post-natal diseases\n* Infant's family history of atopy\n* Any pathology related to the immune or gastrointestinal system.\n* Suspected or known allergy to cow's milk protein\n* Infants receiving pre or probiotics within less than 15 days prior to enrolment\n* Infant's family who in the investigator's assessment cannot be expected to comply with the protocol"}, 'identificationModule': {'nctId': 'NCT02096302', 'acronym': 'GO-INF', 'briefTitle': 'The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Ordesa'}, 'officialTitle': 'Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales', 'orgStudyIdInfo': {'id': 'GO-INF-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Formula', 'description': 'Infant formula with a novel probiotic CECT7210', 'interventionNames': ['Dietary Supplement: Infant Formula with a novel probiotic CECT7210']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Formula', 'description': 'Standard infant formula without probiotics', 'interventionNames': ['Dietary Supplement: Standard formula']}], 'interventions': [{'name': 'Infant Formula with a novel probiotic CECT7210', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.', 'armGroupLabels': ['Experimental Formula']}, {'name': 'Standard formula', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standard formula without probiotics', 'armGroupLabels': ['Standard Formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Reus', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}], 'overallOfficials': [{'name': 'Isabel Polanco, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario La Paz'}, {'name': 'Joaquin Escribano, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Sant Joan de Reus, Reus, Spain'}, {'name': 'Ricardo Closa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Joan XXIII de Tarragona, Tarragona, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Ordesa', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Harrison Clinical Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}