[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501740":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":32,"responsibleParty":50,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Control",null,"Women not exposed to antibiotics throughout the entire duration of pregnancy",{"label":13,"type":10,"description":14,"interventionNames":15},"Prenatal antibiotics","Women exposed to antibiotics for at least 7 days from the 32nd week of gestation",[16],"Drug: Antibiotics",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","Antibiotics","Any antibiotic therapy administered \\> 7 days",[13],[24],{"name":25,"affiliation":5,"role":26},"Carlo Pietrasanta, MD,PhD","PRINCIPAL_INVESTIGATOR",[28],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+393337505802","carlo.pietrasanta@unimi.it",[33],{"facility":34,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","RECRUITING","Milan","20122","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],9.18951,45.46427,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":30,"phoneExt":10,"email":49},"carlo Pietrasanta, MD","carlo.pietrasanta@gmail.com",{"type":26,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Carlo Pietrasanta","Senior Researcher, Principal Investigator",[54],{"name":55,"class":6},"Humanitas Hospital, Italy","100501740","prenatal-antibiotics-and-breast-milk--neonatal-iga-100501740",false,"NCT05813184","Prenatal Antibiotics and Breast Milk \u002F Neonatal IgA","Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA","PAIGAN 1","Inclusion Criteria:\n\n* expression of written informed consent\n* an antibiotic treatment (any molecule) for at least 7 days consecutively after the 32 weeks of pregnancy (or the absence of exposure to any systemic antibiotic treatment during pregnancy for the control group)\n* the intention to breastfeed their neonates as long as possible during the first year of life\n\nExclusion Criteria:\n\n* absence of written informed consent\n* the intention to formula feed exclusively (or the presence of significant maternal concerns about breastfeeding)\n* a maternal antibiotic treatment shorter than 7 days\n* the presence of pre-existing maternal immune-mediated disorders (including immunodeficiencies and chronic infectious diseases)\n* a delivery at a gestational age \\\u003C 34 weeks\n* the administration of antibiotics to neonates after birth, within the first week of life.","FEMALE","18 Years","40 Years",{"count":68,"type":69},82,"ESTIMATED","OBSERVATIONAL","In this biological study, the investigators will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation",[73,74,75,76,77],"Prenatal Exposure Delayed Effects","Antibiotic Prophylaxis","Dysbiosis","Neonatal Infection","Breast Milk; Noxious Influence, Affecting Fetus",[79,13,80,81,82],"IgA","breast milk","feces","neonatal immune system","2024-06-24",{"date":85,"type":86},"2024-06-26","ACTUAL",{"date":88,"type":86},"2023-10-08",{"date":90,"type":69},"2025-10-30",{"name":5,"class":6},1]