[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":58,"collaborators":61,"id":72,"slug":25,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Cape Town","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"B. infantis Rosell®-33","ACTIVE_COMPARATOR","Participants will receive 8 x 109 CFU B. infantis Rosell®-33 per dose (single microbial active ingredient) and carrier material (maltodextrin) for 28 days from day 1-3 of life.",[13],"Dietary Supplement: B. infantis Rosell®-33",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo (containing all materials besides B. infantis Rosell®-33) for 28 days from day 1-3 of life.",[19],"Dietary Supplement: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","B. infantis Rosell®-33 + maltodextrin",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Maltodextrin",[15],[30],{"name":31,"affiliation":32,"role":33},"Heather Jaspan, MD PHD","Seattle Children's Hospital","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","2068543336","hbjaspan@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Anna-Ursula Happel, PhD","+ 27 21 406 6823","anna.happel@uct.ac.za",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":25,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Khayelitsha Site B Midwife Obstetric Unit","RECRUITING","Cape Town","South Africa",{"type":50,"coordinates":51},"Point",[52,53],18.42322,-33.92584,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":25,"phoneExt":25,"email":25},"Busi Tyhenge",{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Anna-Ursula Happel","Professor",[62,63,65,67,70],{"name":32,"class":6},{"name":64,"class":6},"University of Stellenbosch",{"name":66,"class":6},"Institute for Systems Biology",{"name":68,"class":69},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":71,"class":6},"University of Washington","100510199",false,"NCT05923333","B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV","Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial","BifIID","Inclusion Criteria Mother:\n\n* Willing and able to provide signed and dated informed consent form\n* 18 years of age or older\n* Documented HIV seropositive\n* Antiretroviral therapy initiated before the third trimester of pregnancy\n* Planning on exclusively breastfeeding the infant for the first 6 months of life\n\nInclusion Criteria Infant:\n\n* Documented HIV seronegative at birth\n* Born at term (completed at least 37 weeks of gestation)\n* Birth weight \\>2.4kgs\n\nExclusion Criteria:\n\n* Severe illnesses, e.g. Sepsis\n* current TB or known household TB contact\n* Chronic disorder or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that in the opinion of the investigator would alter immunity\n* Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections\n* Known contraindications to components of the interventional products\n* Taking additional probiotics or prebiotics\n* Any condition that in the opinion of the investigator would make participation in the trial unsafe",true,"ALL","0 Days","50 Years",{"count":84,"type":85},200,"ESTIMATED","INTERVENTIONAL",[88],"NA","The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on:\n\n* gut microbiome composition and diversity at 4 weeks of life\n* markers of intestinal inflammation and microbial translocation at 4 weeks of life\n* Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life\n\nThe secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on:\n\n* longitudinal succession of the gut microbiota composition, diversity and function\n* relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life\n* stool metabolome\n* T cell subset ontogeny during the first 9 months of life.\n\nExploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves:\n\n* infant growth\n* all-cause morbidity\n* neurodevelopment during the first 9 months of life\n* antibody responses to early childhood vaccines",[91,92,93,94],"Hiv","Vaccine Reaction","Microbial Colonization","Infant Development","2024-08-20",{"date":97,"type":98},"2024-08-22","ACTUAL",{"date":100,"type":98},"2023-08-11",{"date":102,"type":85},"2027-06",{"name":5,"class":6},1]