[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566133":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":10,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Breast feeding",null,"Exclusively breastfed infants for 2 months",[13,14],"Other: Stool analysis","Other: breast milk analysis",{"label":16,"type":10,"description":17,"interventionNames":18},"Non breast feeding","Infants exclusively fed with formula milk",[13],[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Stool analysis","Analysis of infant fecal microbiota",[9,16],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"breast milk analysis","Analysis of the effect of breast milk miRNAs on infant fecal microbiota",[9],[29],{"name":30,"affiliation":5,"role":31},"Alexis MOSCA, MD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","0187891646","alexis.mosca@aphp.fr",{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},"Servane ALIROL-BECHON, PhD","01.87.89.16.46","servane.alirol-bechon@aphp.fr",[42],{"facility":43,"status":10,"city":44,"state":10,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Robert Debre Hospital Assistance Publique Hôpitaux de Paris","Paris","75019","France","FR",{"type":49,"coordinates":50},"Point",[51,52],2.3488,48.85341,{"lat":52,"lon":51},[55,56],{"name":30,"role":34,"phone":39,"phoneExt":10,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[60],{"name":61,"class":62},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV","100566133","impact-of-breast-milk-mirnas-on-the-infant-gut-microbiota-100566133",false,"NCT06651216","Impact of Breast Milk miRNAs on the Infant Gut Microbiota","MiMilk","Inclusion Criteria:\n\n* Pregnant women in the 3rd trimester of pregnancy (3T) with a normal course of pregnancy up to 39 weeks consulting for the monitoring visit at the Robert-Debré hospital.\n* Patients who did not receive antibiotic treatment or probiotics in 3T.\n* Patient with a negative PV for Strepto B\n* Patients who do not have complications such as pre-eclampsia or gestational diabetes.\n* Breastfeeding (+\u002F- milk pump) or exclusive artificial breastfeeding.\n* No opposition from the mother\n* Ability to master the French language required.\n* Freezer at home.\n* Affiliation to a social security scheme.\n\nExclusion Criteria:\n\n* Cesarean delivery\n* Perinatal pathologies (Anoxia, IUGR, etc.)\n* Neonatal pathologies (FGR, malformations, etc.)\n* Initial choice of mixed breastfeeding\n* Patient under AME (State Medical Aid)Critères d'exclusions :\n* Antibiotics for the mother or child before day 60\n* Antifungal for the mother or child before day 60\n* Complete cessation of breastfeeding before day 60",true,"FEMALE","18 Years","50 Years",{"count":75,"type":76},200,"ESTIMATED","OBSERVATIONAL","The first 1000 days of life are a critical period for future health. A healthy gut microbiota (GM) is essential for preventing both short-term and long-term health issues. Breast milk (BM) plays a key role in establishing the GM, as, unlike formula milk, it contains miRNAs that may interact with and modulate the microbiota.\n\nPrimary Objective: To study the effect of BM on the composition of fecal miRNAs in exclusively breastfed infants compared to those fed with formula milk at different times (D10, D30, D60, M6, M12).\n\nSecondary Objectives:\n\nAnalyze the effect of BM miRNAs on infant fecal microbiota, taking environmental confounding factors into account.\n\nStudy the influence of BM microbiota on miRNA profiles in the milk. Examine the effect of BM microbiota on the infants' gut microbiota. Explore the links between BM miRNAs, infant gut microbiota, and intestinal inflammation.",[80,81],"Breast Milk","Stools","NOT_YET_RECRUITING","2024-10-18",{"date":85,"type":86},"2024-10-21","ACTUAL",{"date":88,"type":76},"2024-11-01",{"date":90,"type":76},"2027-05-31",{"name":5,"class":6},1]