Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-25 @ 11:50 PM
Study NCT ID:
NCT01531192
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2012-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
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Blood culture for Candida infection will be taken weekly.'}], 'secondaryOutcomes': [{'measure': 'Effect of Lactobacillus reuteri on feeding intolerance', 'timeFrame': 'up to 6 months', 'description': 'Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)'}, {'measure': 'Effect of Lactobacillus reuteri on sepsis', 'timeFrame': 'up to 6 months', 'description': 'Patients with culture positivity will accept as proven sepsis.'}, {'measure': 'Effect of Lactobacillus reuteri on length of hospital stay', 'timeFrame': 'up to 6 months', 'description': 'Specified length of hospital stay as days.'}, {'measure': 'Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants', 'timeFrame': 'up to 6 months', 'description': "NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lactobacillus reuteri', 'Nystatin', 'Very Low Birth Weight Infants', 'Candida Colonization'], 'conditions': ['Very Low Birth Weight Infants']}, 'referencesModule': {'references': [{'pmid': '25245226', 'type': 'DERIVED', 'citation': 'Oncel MY, Arayici S, Sari FN, Simsek GK, Yurttutan S, Erdeve O, Saygan S, Uras N, Oguz SS, Dilmen U. Comparison of Lactobacillus reuteri and nystatin prophylaxis on Candida colonization and infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2015;28(15):1790-4. doi: 10.3109/14767058.2014.968842. Epub 2014 Oct 9.'}], 'seeAlsoLinks': [{'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=L040030000&QV1=LACTOBACILLUS+REUTERI', 'label': 'Lactobacillus reuteri'}, {'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0001400619&QV1=NYSTATIN', 'label': 'Nystatin'}]}, 'descriptionModule': {'briefSummary': 'Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Very low birth weight infants \\< 1500 gr\n* Gestational age \\< 32 weeks\n\nExclusion Criteria:\n\n* Genetic anomalies\n* Short bowel syndrome\n* Not willing to participate\n* Allergy to Lactobacillus reuteri components'}, 'identificationModule': {'nctId': 'NCT01531192', 'briefTitle': 'Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey', 'orgStudyIdInfo': {'id': 'ZTB630301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus reuteri', 'description': 'Lactobacillus reuteri 100 million CFU/day for 3 months', 'interventionNames': ['Dietary Supplement: Lactobacillus reuteri']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nystatin', 'description': '50000 unit/3 times a day', 'interventionNames': ['Drug: Nystatin']}], 'interventions': [{'name': 'Lactobacillus reuteri', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BioGaia'], 'description': 'Lactobacillus reuteri 100 million CFU/day for 3 months', 'armGroupLabels': ['Lactobacillus reuteri']}, {'name': 'Nystatin', 'type': 'DRUG', 'otherNames': ['Mikostatin'], 'description': '50000 unit/3 times a day, both for orally and by orogastric route', 'armGroupLabels': ['Nystatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mehmet Yekta Oncel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neonatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Yekta', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}