[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617566":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":51,"locations":59,"responsibleParty":75,"collaborators":77,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":31,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":31,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":31,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Anabio R&D","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo group","PLACEBO_COMPARATOR","The Placebo group receives reverse osmosis (RO) water with a dosage of 1 ampoule per day for 90 days.",[13],"Other: RO water",{"label":15,"type":16,"description":17,"interventionNames":18},"Pregmom group","EXPERIMENTAL","The Pregmom group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU\u002F5 mL (LiveSpo PREG-MOM) with a dosage of 1 ampoule per day for 90 days.",[19],"Combination Product: LiveSpo PREG-MOM",{"label":21,"type":16,"description":22,"interventionNames":23},"Consy group","The Consy group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 4 billion CFU\u002F5 mL (LiveSpo CONSY) with a dosage of 1 ampoule per day for 90 days.",[24],"Combination Product: LiveSpo CONSY",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"OTHER","RO water","RO water (Aquafina, PepsiCo) produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LIVESPO PREG-MOM\u002FCONSY but contain 5 mL of high-quality RO water from Aquafina.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"COMBINATION_PRODUCT","LiveSpo PREG-MOM","LiveSpo PREG-MOM has a registration number 7695\u002F2020\u002FĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.",[15],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"LiveSpo CONSY","LiveSpo CONSY has a registration number 4165\u002F2020\u002FĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.",[21],[42,46,49],{"name":43,"affiliation":44,"role":45},"Hung T Mai, PhD","Hanoi Obstetrics and Gynecology Hospital","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":44,"role":48},"Chuong C Nguyen","STUDY_CHAIR",{"name":50,"affiliation":5,"role":48},"Anh TV Nguyen, Assoc.Prof.PhD",[52,56],{"name":43,"role":53,"phone":54,"phoneExt":31,"email":55},"CONTACT","(+84) 988.855.888","bacsymaitronghung@gmail.com",{"name":47,"role":53,"phone":57,"phoneExt":31,"email":58},"(+84)913368526","chuongnc2912@gmail.com",[60],{"facility":44,"status":31,"city":61,"state":31,"zip":31,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Hanoi","Vietnam","VN",{"type":65,"coordinates":66},"Point",[67,68],105.84117,21.0245,{"lat":68,"lon":67},[71],{"name":72,"role":53,"phone":73,"phoneExt":31,"email":74},"Hue TK Ta","(+84) 972467431","huettkpshn@gmail.com",{"type":76,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[78],{"name":44,"class":27},"100617566","effects-of-multi-strain-bacillus-spore-probiotics-on-growth-digestive-function-and-gut-microbiota-in-cesarean-delivered-neonates-100617566",false,"NCT07320287","Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates","A Randomized, Blinded, Controlled Trial to Evaluate Effects of Multi-strain Bacillus Spore Probiotic Supplements (LiveSpo PREG-MOM and LiveSpo CONSY) on Growth Metrics, Prevention of Functional Gastrointestinal Disorders, and Modulation of the Gut Microbiota in Cesarean-Delivered Neonates","Inclusion Criteria:\n\n* Healthy term neonates delivered by cesarean section.\n* Infants were born at term, ranging from 38 to 40 weeks' gestation.\n* Birth weight appropriate for gestational age (AGA), defined as between the 10th and 90th percentiles for gestational age (≥P10 and ≤P90).\n* The infant's parent(s) or legal guardian(s) provide written informed consent and agree to comply with study procedures.\n\nExclusion Criteria:\n\nFor the neonate:\n\n* Multiple births (twins, triplets, etc.)\n* Birth weight outside the appropriate-for-gestational-age range: small for gestational age (SGA, \\\u003C P10) or large for gestational age (LGA, \\> P90).\n* Major congenital abnormalities affecting the hematologic, hepatobiliary, cardiovascular, renal\u002Furinary, or gastrointestinal systems; severe inborn errors of metabolism; or suspected primary immunodeficiency.\n* Prior exposure to systemic or enteral antibiotics (oral, IV, or IM) before the baseline assessment.\n* Known allergy or intolerance to any component of the investigational product.\n* Concurrent participation in another interventional clinical trial.\n* The investigators judge the neonate to be unsuitable for participation.\n* Parent(s) or legal guardian(s) who do not comply with study requirements or refuse to sign the informed consent.\n\nFor the mother:\n\n* Mother diagnosed with a serious or unstable medical condition involving the hepatobiliary, renal\u002Furinary, cardiovascular, respiratory, endocrine\u002Fmetabolic, or psychiatric systems.\n* Mother who intends to use, or is prescribed, any other probiotic\u002Fprebiotic product for herself or the infant during the study period.",true,"ALL","0 Days","1 Day",{"count":91,"type":92},180,"ESTIMATED","INTERVENTIONAL",[95],"NA","Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and increased Proteobacteria. This early microbial alteration has been associated with functional gastrointestinal disorders (FGIDs), including colic, regurgitation, and changes in stool frequency and consistency, which may in turn affect early growth and overall gastrointestinal functioning. Probiotic supplementation is considered a safe and feasible strategy to support microbial restoration and improve digestive function during the first months of life.\n\nIn this study, researchers propose that daily supplementation with multi-strain Bacillus spore probiotics may help support healthy early growth, reduce functional gastrointestinal symptoms, and promote a more balanced gut microbiota in cesarean-delivered infants.\n\nThe objective of this study is to evaluate the safety and efficacy of two oral probiotic formulations, LiveSpo PREG-MOM and LiveSpo CONSY, containing multi-strain B. subtilis ANA46, B. clausii ANA39, and B. coagulans ANA40 at respective 3 and 4 billion colony-forming units (CFU)\u002F5 mL ampoule, administered 1 ampoule daily, during the first 90 days of life. The study examines effects on growth, digestive symptoms, immune markers, and microbial composition.\n\nStudy Design: This randomized, blind, controlled clinical trial will enroll 180 healthy full-term cesarean-born infants at Hanoi Obstetrics and Gynecology Hospital.\n\nIntervention Description: Participants will be randomly assigned to three groups (n = 60 each). All groups will receive one 5-mL ampoule daily for 90 days: LiveSpo PREG-MOM, LiveSpo CONSY, or placebo. Stool samples will be collected at several follow-up time points to assess digestive health and microbial development. All products will be provided in blinded and coded packaging to maintain objectivity.\n\nStudy Duration: 12 months",[98,99],"Functional Gastrointestinal Disorders (FGIDs)","Weight Loss",[101,102,103],"Cesarean-born Infants","Gut Dysbiosis","Bacillus spore","NOT_YET_RECRUITING","2026-01-06",{"date":107,"type":108},"2026-01-07","ACTUAL",{"date":107,"type":92},{"date":111,"type":92},"2027-01-07",{"name":5,"class":6},1]