Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-28 @ 7:09 AM
Study NCT ID:
NCT01891604
Status:
WITHDRAWN
Last Update Posted:
2017-05-12
First Post:
2013-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study the Safety and Efficacy of Probiotics Use in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007235', 'term': 'Infant, Premature, Diseases'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study Never Initiated due to Impact approval from institution not being obtinaed', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-28', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calprotectin will be used to determine the effect for probiotics', 'timeFrame': 'day1 and day30 of the observation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infant, Premature, Diseases']}, 'descriptionModule': {'briefSummary': "Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* born with weight\\<1500 g\n* hospitalized within 48 hours after birth\n\nExclusion Criteria:\n\n* present with evidence or suspicion of congenital intestinal obstruction\n* perforation\n* gastroschisis\n* large omphalocele\n* congenital diaphragmatic hernia\n* major congenital heart defects'}, 'identificationModule': {'nctId': 'NCT01891604', 'briefTitle': 'Study the Safety and Efficacy of Probiotics Use in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Study the Safety and Efficacy of Probiotics Use in Premature Infants', 'orgStudyIdInfo': {'id': 'jamesfriel2013'}}, 'armsInterventionsModule': {'interventions': [{'name': 'breast milk with Bifidobacterium Longum subp. Infantis R0033', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'breast milk', 'type': 'DIETARY_SUPPLEMENT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lallemand Health Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. James Friel', 'investigatorAffiliation': 'University of Manitoba'}}}}