[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":62,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"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,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Khayelitsha Site B Midwife Obstetric Unit","RECRUITING","Cape Town","South Africa","ZA",{"type":51,"coordinates":52},"Point",[53,54],18.42322,-33.92584,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":25,"phoneExt":25,"email":25},"Busi Tyhenge",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Anna-Ursula Happel","Professor",[63,64,66,68,71],{"name":32,"class":6},{"name":65,"class":6},"University of Stellenbosch",{"name":67,"class":6},"Institute for Systems Biology",{"name":69,"class":70},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":72,"class":6},"University of Washington","100510199","b-infantis-supplementation-to-improve-immunity-in-infants-exposed-to-hiv-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":86,"type":87},200,"ESTIMATED","INTERVENTIONAL",[90],"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",[93,94,95,96],"Hiv","Vaccine Reaction","Microbial Colonization","Infant Development","2024-08-20",{"date":99,"type":100},"2024-08-22","ACTUAL",{"date":102,"type":100},"2023-08-11",{"date":104,"type":87},"2027-06",{"name":5,"class":6},1]