Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT00437567
Status:
UNKNOWN
Last Update Posted:
2014-01-03
First Post:
2007-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prebiotics in the Prevention of Necrotizing Enterocolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072242', 'term': "4'-galactooligosaccharide"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2007-02-08', 'studyFirstSubmitQcDate': '2007-02-19', 'lastUpdatePostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Necrotizing Enterocolitis', 'timeFrame': 'yearly'}], 'secondaryOutcomes': [{'measure': 'fecal calprotectin, urine IFABP', 'timeFrame': 'end of study'}, {'measure': 'NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]', 'timeFrame': 'yearly'}, {'measure': 'Stool bifidobacteria', 'timeFrame': 'End of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['galacto-oligosaccharides', 'prebiotics', 'NEC'], 'conditions': ['Necrotizing Enterocolitis']}, 'referencesModule': {'references': [{'pmid': '16126048', 'type': 'BACKGROUND', 'citation': 'Bin-Nun A, Bromiker R, Wilschanski M, Kaplan M, Rudensky B, Caplan M, Hammerman C. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005 Aug;147(2):192-6. doi: 10.1016/j.jpeds.2005.03.054.'}]}, 'descriptionModule': {'briefSummary': 'Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of \\<1500 gm. NEC is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. We have previously demonstrated a protective effect of probiotic administration against the development of NEC. Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.', 'detailedDescription': 'Specifically, we hope to demonstrate that fewer of the babies who are treated with galacto-oligosaccharides (GOS) will develop NEC as compared with controls.\n\nPreterm neonates, \\<1750 gm birth weight will potentially be candidates for study. They will be randomly assigned to receive one of two milk additives from the time enteral feeds are begun until 35 weeks post-conceptual age: prebiotics (GOS) or placebo (water). All infants will be followed prospectively for signs of feeding intolerance and/or development of NEC. These will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates\n* \\< 1750 gm birth weight\n\nExclusion Criteria:\n\n* Infants who are deemed unlikely to survive\n* Infants with significant congenital malformations\n* Infants with other gastrointestinal problems'}, 'identificationModule': {'nctId': 'NCT00437567', 'briefTitle': 'Prebiotics in the Prevention of Necrotizing Enterocolitis', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates', 'orgStudyIdInfo': {'id': 'SZMC/CH/32007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prebiotics', 'description': 'Babies randomized to this arm will receive galacto-oligosaccharide supplements', 'interventionNames': ['Dietary Supplement: Galacto-oligosaccharide (GOS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Babies randomized to this arm will receive placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Galacto-oligosaccharide (GOS)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.', 'armGroupLabels': ['Prebiotics']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Similar quantity of sterile water to be added to milk', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91031', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Cathy Hammerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alona Bin-nun, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Cathy Hammerman, MD', 'role': 'CONTACT', 'email': 'cathy@cc.huji.ac.il', 'phone': '9722 666-6238'}, {'name': 'Alona Bin-nun, MD', 'role': 'CONTACT', 'email': 'alona.binnun@gmail.com', 'phone': '97250 868-5757'}], 'overallOfficials': [{'name': 'Cathy Hammerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Cathy Hammerman', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}