Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-04 @ 12:01 PM
Study NCT ID:
NCT03163212
Status:
UNKNOWN
Last Update Posted:
2017-05-22
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose escalation design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2017-05-19', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Definitely related study solution serious adverse event', 'timeFrame': '30 days while receiving study solution'}], 'secondaryOutcomes': [{'measure': 'Day after birth to reach 120ml/kg of enteral feeds', 'timeFrame': '30 days while receiving study solution'}, {'measure': 'Number of days not receiving any feedings after lactoferrin/FOS administration', 'timeFrame': '30 days while receiving study solution'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lactoferrin/FOS Supplementation'], 'conditions': ['Safety Issues', 'Tolerance', 'Very Low Birth Weight Infant']}, 'descriptionModule': {'briefSummary': "This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.", 'detailedDescription': 'Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants\n\n1. Lactoferrin/FOS related adverse events and serious adverse events\n2. Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)\n3. Episodes of not receiving enteral feedings for \\> 24 hours once feeding is initiated\n\nAim 2: To evaluate lactoferrin/FOS absorption and excretion\n\n1. Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool\n2. Examine lactoferrin levels in materal and human donor milk\n\nAim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\< 15 days of age and receiving enteral feedings\n* \\< 1500 grams birth weight\n* \\< 37 weeks gestation\n\nExclusion Criteria:\n\n* Congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)\n* Known necrotizing enterocolitis or bowel perforation'}, 'identificationModule': {'nctId': 'NCT03163212', 'briefTitle': 'Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants', 'orgStudyIdInfo': {'id': '19804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactoferrin/FOS 100mg/kg', 'description': '100 mg/kg enteral administration daily for 30 days', 'interventionNames': ['Dietary Supplement: Lactoferrin/FOS']}, {'type': 'EXPERIMENTAL', 'label': 'Lactoferrin/FOS 200mg/kg', 'description': '200 mg/kg enteral administration daily for 30 days', 'interventionNames': ['Dietary Supplement: Lactoferrin/FOS']}, {'type': 'EXPERIMENTAL', 'label': 'Lactoferrin/FOS 300mg/kg', 'description': '300 mg/kg enteral administration daily for 30 days', 'interventionNames': ['Dietary Supplement: Lactoferrin/FOS']}], 'interventions': [{'name': 'Lactoferrin/FOS', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BF100'], 'description': 'Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water', 'armGroupLabels': ['Lactoferrin/FOS 100mg/kg', 'Lactoferrin/FOS 200mg/kg', 'Lactoferrin/FOS 300mg/kg']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David A Kaufman, MD', 'role': 'CONTACT', 'email': 'dak4r@virginia.edu', 'phone': '434-924-5428'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Specimens which have been unidentified may be shared with outside labs for analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Gerber Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': 'David A Kaufman', 'investigatorAffiliation': 'University of Virginia'}}}}