[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cesarean-delivery-affecting-newborn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cesarean-delivery-affecting-newborn":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":42,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":5},"100609268","infant-microbiota-restoration-with-maternal-microbes-100609268",false,"NCT07212361","Infant Microbiota Restoration With Maternal Microbes","MaMi","Inclusion Criteria:\n\n* Healthy mother and healthy pregnancy\n* Singleton pregnancy,\n* Mothers who speak Finnish or Swedish\n* Mothers who are planning to breastfeed or give breastmilk by bottle to the infant\n* Infants who are expected to be healthy and who will not require BCG vaccination.\n\nExclusion Criteria:\n\n* Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland\n* Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant\n* Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery\n* Premature infants born before the pregnancy week 37\n* Infants, who are born by urgent cesarean section or emergency cesarean section\n* Infants, who receive antibiotics during the first week of life\n* Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.\n* Infants, who receive BCG-vaccine",true,"ALL","50 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:\n\nDo maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.\n\nParticipants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Infant, Newborn","Gut -Microbiota","Gut Dysbiosis","Cesarean Delivery Affecting Newborn","Cesarean Section","Vaginal Delivery","Gastrointestinal Microbiota","Microbiota, Cesarean Section, Probiotics, Dysbiosis","Feces","Delivery, Obstetric","Microbiota","Microbiology","Humans","Pregnancy","Neonate",[43,44,45,46,47,48],"Infant","newborn","cesarean section","neonate","restore","gut microbiota","RECRUITING","2025-09-30",{"date":52,"type":53},"2025-10-08","ACTUAL",{"date":55,"type":53},"2025-07-17",{"date":57,"type":21},"2035-12-31",{"name":59,"class":60},"University of Helsinki","OTHER",{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":16,"sex":17,"minAge":68,"maxAge":18,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100308670","phase-1-vaginal-microbiome-seeding-and-health-outcomes-in-cesarean-delivered-neonates-100308670","NCT03298334","Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.","Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial","Inclusion Criteria for Mother:\n\n* Scheduled for cesarean delivery at ≥ 37 weeks\n* Pregnant with single fetus, in good general health, age 18 years or older\n* Negative maternal testing for infections transmitted through vaginal and\u002For other body fluids performed as standard of care tests in early pregnancy\n* Negative testing for Group B strep at 35-37 weeks gestation\n* Vaginal pH ≤ 4.5 indicative of Lactobacillus-dominated vaginal microbiota\n* No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol\n* English or Spanish speaking\n* Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later\n* Women aged 18-29 years must have a normal Pap test within 3 years\n* Women aged 30-65 years must have a normal Pap test and an HPV test (co-testing) within 5 years or FDA-approved primary hrHPV testing alone within 5 years or a normal Pap test alone within 3 years\n* Negative maternal testing for SARS-CoV-2 for the delivery admission performed as standard of care test at the Inova Health System.\n\nInclusion Criteria for Infant:\n\n* Infant condition after delivery requires no more than standard neonatal resuscitation\\* or is otherwise medically unable to receive the full VMT procedure\n\n\\[\\*\\] Standard neonatal resuscitation may include: tactile stimulation, bulb suction, oxygen without positive pressure, or drying\n\nExclusion Criteria for Mother:\n\n* Delivery at a hospital other than Inova Health System\n* Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions\n* Rupture of membranes prior to scheduled cesarean delivery\n* Bacterial vaginosis within 30 days of cesarean delivery\n* Symptomatic urinary tract infection within 30 days of cesarean delivery\n* Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)\n* Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness\n* Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions\n* History of genital HSV\n* History positive testing for Group B strep infection\n* History of a child with a diagnosis of Group B strep sepsis\n* Pregnancy a result of donor egg or surrogacy\n* Preexisting history of Type I or Type II Diabetes\n* Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination\n* Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms on admission suggesting potential Covid-19 infection","0 Days",{"count":70,"type":21},600,[72,73],"PHASE1","PHASE2","Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.",[30,76,77,37,78,79],"Obesity, Childhood","Intestinal Microbiome","Host Microbial Interactions","Gastrointestinal Microbiome","2025-06-04",{"date":82,"type":53},"2025-06-08",{"date":84,"type":53},"2018-07-01",{"date":86,"type":21},"2029-04",{"name":88,"class":89},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1]