Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-01 @ 10:10 PM
Study NCT ID:
NCT01454661
Status:
UNKNOWN
Last Update Posted:
2018-04-19
First Post:
2011-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics and Early Microbial Contact in Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2011-10-10', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiota', 'timeFrame': '1 month', 'description': 'Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life'}], 'secondaryOutcomes': [{'measure': 'Intestinal immunity', 'timeFrame': '1 month', 'description': 'Intestinal immune gene expression profiles will be assessed from fecal samples.'}, {'measure': 'Breast milk compostion', 'timeFrame': '1 months', 'description': 'Immunological and microbiological properties of breast milk will be investigated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Premature infant', 'Intestinal microbiota', 'Intestinal immunity', 'Breastfeeding'], 'conditions': ['Premature; Infant, Light-for-dates', 'Breastfeeding']}, 'descriptionModule': {'briefSummary': 'Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic intervention is yet to be established. The mechanisms by which probiotics exert their effects remain largely unknown.\n\nThis research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. In particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. All of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. The purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial.\n\nThe specific aims of the project are:\n\n1. To determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. Concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured.\n2. To investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. In particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. Different potential probiotic strains will be assessed.\n3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premature infant born at \\<35 weeks gestational age\n\nExclusion Criteria:\n\n* severe asphyxia\n* significant anomalies'}, 'identificationModule': {'nctId': 'NCT01454661', 'acronym': 'ProPre', 'briefTitle': 'Probiotics and Early Microbial Contact in Preterm Neonates', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Probiotic Modulation of Early Microbial Contact in Premature Infants', 'orgStudyIdInfo': {'id': 'ETMK 104/180/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'placebo mother - LGG infant', 'description': 'Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.', 'interventionNames': ['Dietary Supplement: LGG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo mother - placebo infant', 'description': 'Placebo is administered to both the lactating mother and her infant.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LGG mother - placebo infant', 'description': 'The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.', 'interventionNames': ['Dietary Supplement: LGG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LGG+Bb-12 mother - Placebo infant', 'description': 'A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo.', 'interventionNames': ['Dietary Supplement: LGG+Bb-12']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pacebo mother - LGG+Bb-12 infant', 'description': 'Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12', 'interventionNames': ['Dietary Supplement: LGG+Bb-12']}], 'interventions': [{'name': 'LGG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactobacillus rhamnosus GG 10E9 cfu / day', 'armGroupLabels': ['LGG mother - placebo infant', 'placebo mother - LGG infant']}, {'name': 'LGG+Bb-12', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.', 'armGroupLabels': ['LGG+Bb-12 mother - Placebo infant', 'Pacebo mother - LGG+Bb-12 infant']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Microcrystalline cellulose is used as placebo.', 'armGroupLabels': ['placebo mother - placebo infant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Samuli Rautava, MD, PhD', 'role': 'CONTACT', 'email': 'samrau@utu.fi', 'phone': '+358 40 7033166'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Samuli Rautava, MD, PhD', 'role': 'CONTACT', 'email': 'samrau@utu.fi', 'phone': '+358 40 7033166'}], 'overallOfficials': [{'name': 'Samuli Rautava, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Samuli Rautava', 'investigatorAffiliation': 'Turku University Hospital'}}}}