Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-25 @ 8:20 PM
Study NCT ID:
NCT02796703
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2016-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat Killed Probiotics 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2016-05-22', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Necrotizing Enterocolitis, Bell Stage 2 or above, or Death', 'timeFrame': 'Birth until 40 weeks post-conceptional age', 'description': 'Necrotizing Enterocolitis diagnosis will be based on clinical and radiographic criteria'}], 'secondaryOutcomes': [{'measure': 'Increased Urine IFABP Levels', 'timeFrame': 'Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age'}, {'measure': 'Increased Fecal Calprotectin Levels', 'timeFrame': 'Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Necrotizing Enterocolitis', 'Enterocolitis, Necrotizing']}, 'referencesModule': {'references': [{'pmid': '20506712', 'type': 'BACKGROUND', 'citation': 'Awad H, Mokhtar H, Imam SS, Gad GI, Hafez H, Aboushady N. Comparison between killed and living probiotic usage versus placebo for the prevention of necrotizing enterocolitis and sepsis in neonates. Pak J Biol Sci. 2010 Mar 15;13(6):253-62. doi: 10.3923/pjbs.2010.253.262.'}]}, 'descriptionModule': {'briefSummary': 'Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies. Based on animal data, the investigators hypothesized that heat inactivated probiotics would also reduce NEC.', 'detailedDescription': "Preterm neonates, \\<1500 gm birth weight will potentially be candidates for study and will be recruited when they begin enteral feeding. The infants will be prospectively and randomly assigned to one of two groups:\n\n1. Treatment group - to receive daily inactivated probiotic prophylaxis starting with the initiation of feeds. 1 tsp powder will be diluted in 2 cc of mother's milk when possible or in Similac Special Care formula 24 cal when mother's milk is not available; and\n2. Control group - to receive 2 cc/day of placebo similarly diluted. Supplements will be continued until the infant tolerates enteral feeds of 100 cc/kg/day or reaches 35 weeks post conceptual age (whichever comes LAST). Biotikid, a probiotic mixture, will be heated to 100 degrees C for 10 minutes. Babies will be followed clinically for signs of NEC, and with urine intestinal fatty acid binding protein (IFABP) and fecal calprotectin levels.\n\nThe investigators primary aim is to demonstrate that premature neonates who are treated prophylactically with heat inactivated probiotics will have less necrotizing enterocolitis when compared to age matched infants given placebo.\n\nThe investigators secondary objectives are to demonstrate the following:\n\n* That the decrease in NEC will coincide with improved intestinal barrier integrity, as reflected by levels of:\n* I-FABP in urine\n* Fecal Calprotectin"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '6 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates\n* ≤1500 gm birth weight\n\nExclusion Criteria:\n\n* Infants who are not deemed likely to survive more than one week;\n* Infants who are not started on enteral feeds by one week of age;\n* Infants who have significant congenital malformations or other gastrointestinal problem'}, 'identificationModule': {'nctId': 'NCT02796703', 'briefTitle': 'Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis (NEC) in Premature Neonates', 'orgStudyIdInfo': {'id': 'SZMC 0297-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': "Dietary Supplement: Placebo 2 cc/day of placebo diluted in mother's milk (when available) or premature formula.", 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group', 'description': "Dietary Supplement: Heat Inactivated Probiotics\n\n1 tsp heat inactivated Biotikid powder will be diluted in 2 cc of mother's milk (when available) or premature formula.", 'interventionNames': ['Dietary Supplement: Heat Inactivated probiotics']}], 'interventions': [{'name': 'Heat Inactivated probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Biotikid, a probiotic mixture, will be heated to 100 degrees Centigrade for 10 minutes to inactivate and then 1 tsp will be diluted in milk and give with feeds to treatment group', 'armGroupLabels': ['Treatment Group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 cc of milk will be given to control group', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Neonatal Intensive Care Unit - Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Cathy Hammerman, MD', 'role': 'CONTACT', 'email': 'cathyh@ekmd.huji.ac.il', 'phone': '0508685238'}, {'name': 'Alona Bin-Nun, MD', 'role': 'CONTACT', 'email': 'alona.binnun@gmail.com', 'phone': '0508685757'}], 'overallOfficials': [{'name': 'Cathy Hammerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Division Newborn Nurseries', 'investigatorFullName': 'Cathy Hammerman', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}