Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-24 @ 7:21 AM
Study NCT ID:
NCT03154866
Status:
UNKNOWN
Last Update Posted:
2017-05-18
First Post:
2017-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2017-05-10', 'studyFirstSubmitQcDate': '2017-05-14', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample', 'timeFrame': '21 days after supplementation start', 'description': 'To evaluate the ability of Lactobacillus kefiri LKF01 DSM32079 (LKEF) to colonize the intestinal environment of newborns born by caesarian section and modify the gut microbiota composition by using a Next Generation Sequencing technology.\n\nPresence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample.'}, {'measure': 'Number of participants with treatment-related adverse event', 'timeFrame': 'During 21 days after supplementation', 'description': 'A structured diary on possible treatment-related adverse event will be given to mothers.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lactobacillus kefiri LKF01 DSM32079', 'Microbial Colonization'], 'conditions': ['Caesarean Section;Stillbirth', 'Microbial Colonization']}, 'descriptionModule': {'briefSummary': "The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life.\n\nProbiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '1 Hour', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term newborn\n* Adeguate for gestational age\n* Born by elective cesarean section\n* Otherwise healthy newborn\n\nExclusion Criteria:\n\n* major acute or chronic disease\n* use of probiotics/antibiotics\n* gastrointestinal malformation, cystic fibrosis, other genetic diseases\n* concurrent participation in other clinical trials'}, 'identificationModule': {'nctId': 'NCT03154866', 'briefTitle': 'Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section', 'orgStudyIdInfo': {'id': 'KEFINEO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus kefiri LKF01 DSM32079', 'interventionNames': ['Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus kefiri LKF01 DSM32079', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days', 'armGroupLabels': ['Lactobacillus kefiri LKF01 DSM32079']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo in drop formulation. 5 drop/daily for 21 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Maria Elisabetta Baldassarre', 'investigatorAffiliation': 'Policlinico Hospital'}}}}