Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT00808756
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2008-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Fermentable Carbohydrates in Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2008-12-15', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Children well-being and appropriate growth', 'timeFrame': 'up to 4 months'}], 'secondaryOutcomes': [{'measure': 'Secondary outcomes will be metabolic parameters.', 'timeFrame': 'Up to 4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carbohydrates', 'Infant', 'Intestine', 'Faeces', 'Growth', 'Diet'], 'conditions': ['Infant', 'Growth', 'Nutrition', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '23498848', 'type': 'DERIVED', 'citation': 'Closa-Monasterolo R, Gispert-Llaurado M, Luque V, Ferre N, Rubio-Torrents C, Zaragoza-Jordana M, Escribano J. Safety and efficacy of inulin and oligofructose supplementation in infant formula: results from a randomized clinical trial. Clin Nutr. 2013 Dec;32(6):918-27. doi: 10.1016/j.clnu.2013.02.009. Epub 2013 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.', 'detailedDescription': 'Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born in Reus and Tarragona area\n* Healthy\n* Normal feeding behaviour\n\nExclusion Criteria:\n\n* Serious respiratory, neurological, gastrointestinal or metabolic disorders\n* Infections or other serious diseases that could interfere in normal feeding or growth\n* Parents or guardians cannot be expected to comply with protocol\n* Parents or guardians have not command on Catalan or Spanish language'}, 'identificationModule': {'nctId': 'NCT00808756', 'acronym': 'BAMBINOL', 'briefTitle': 'Study on Fermentable Carbohydrates in Healthy Infants', 'organization': {'class': 'OTHER', 'fullName': 'University Rovira i Virgili'}, 'officialTitle': 'Study on Fermentable Carbohydrates in Healthy Infants', 'orgStudyIdInfo': {'id': 'BAMBINOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Intervention', 'description': 'This group will be fed a diet enriched with fermentable carbohydrates.', 'interventionNames': ['Dietary Supplement: Fermentable carbohydrates.']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2: Placebo.', 'description': 'The placebo group will be fed a diet without addition of fermentable carbohydrates. This placebo formula will have the same nutritional values than the intervention (energy, proteins, carbohydrates, fat, vitamins \\& minerals).', 'interventionNames': ['Other: Standard infant formula.']}, {'type': 'NO_INTERVENTION', 'label': 'BF', 'description': 'The 2 intervention groups will be compared with a breast-fed infants control group.'}], 'interventions': [{'name': 'Fermentable carbohydrates.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infant formula enriched with fermentable carbohydrates.', 'armGroupLabels': ['1: Intervention']}, {'name': 'Standard infant formula.', 'type': 'OTHER', 'description': 'Standard infant formula.', 'armGroupLabels': ['2: Placebo.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43201', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Universitari Sant Joan de Reus', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '43005', 'city': 'Tarragona', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Universitari de Tarragona Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}], 'overallOfficials': [{'name': 'Ricardo Closa, PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Rovira i Virgili & Hospital Universitari Joan XXIII'}, {'name': 'Joaquin Escribano, PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat Rovira i Virgili. Hospital Universitari Sant Joan de Reus.'}, {'name': 'Veronica Luque, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Rovira i Virgili'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rovira i Virgili', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitari Joan XXIII de Tarragona.', 'class': 'OTHER'}, {'name': 'Hospital Universitari Sant Joan', 'class': 'UNKNOWN'}, {'name': 'Institut Investigacio Sanitaria Pere Virgili', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ricardo Closa Monasterolo, MD, PhD', 'investigatorFullName': 'Ricardo Closa-Monasterolo', 'investigatorAffiliation': 'University Rovira i Virgili'}}}}