Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT00977912
Status:
TERMINATED
Last Update Posted:
2013-11-25
First Post:
2009-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, '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': 318}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-22', 'studyFirstSubmitDate': '2009-09-15', 'studyFirstSubmitQcDate': '2009-09-15', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NEC onset', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Antibiotic administration and stool microbiology', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['B. lactis', 'Preterm', 'Necrotizing Enterocolitis (NEC)'], 'conditions': ['Necrotizing Enterocolitis']}, 'referencesModule': {'references': [{'pmid': '37493095', 'type': 'DERIVED', 'citation': 'Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.'}, {'pmid': '33058137', 'type': 'DERIVED', 'citation': 'Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '12 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight between 800 - 1500g\n* Tolerating enteral feeding within 48 hours\n* Having obtained his/her parents or legal representative informed consent\n\nExclusion Criteria:\n\n* Chromosomal abnormality\n* Hydrops featalis\n* Congenital malformation of the gastrointestinal tract\n* Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance\n* Currently participating in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00977912', 'briefTitle': 'Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Prevention of NEC in Preterm Infants With B. Lactis', 'orgStudyIdInfo': {'id': '08.09.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Milk" containing B. Lactis', 'description': '"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.', 'interventionNames': ['Dietary Supplement: Probiotic supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': '"Milk" containing placebo', 'description': '"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.', 'interventionNames': ['Dietary Supplement: Milk containing placebo']}], 'interventions': [{'name': 'Probiotic supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one capsule containing probiotics per day added to milk', 'armGroupLabels': ['"Milk" containing B. Lactis']}, {'name': 'Milk containing placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one capsule containing placebo per day added to milk', 'armGroupLabels': ['"Milk" containing placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2013', 'city': 'Bertsham', 'country': 'South Africa', 'facility': 'University of Witwatersrand & Chris Hani Baragwanath Hospital'}, {'zip': '2000', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2112', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'University of Witwatersrand & Rahima Moosa Mother & Child Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Peter A. Cooper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}