[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479566":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":39,"locations":50,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":31,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":67,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"AB Biotics, SA","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental 1","EXPERIMENTAL","Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.",[13],"Dietary Supplement: Food Supplement 1",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental 2","Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.",[18],"Dietary Supplement: Food Supplement 2",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Sunflower oil",[24],"Dietary Supplement: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","Food Supplement 1","Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops\u002Fday",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Food Supplement 2","Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops\u002Fday",[15],{"type":27,"name":20,"description":37,"armGroupLabels":38,"otherNames":31},"5 drops\u002Fday for 3 months of sunflower oil",[20],[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Gerardo Rodríguez Martínez, MD","CONTACT","654633910","+34","gerard@unizar.es",{"name":47,"role":42,"phone":48,"phoneExt":31,"email":49},"Meritxell Aguilo Garcia, PhD","+34902903844","aguilo@ab-biotics.com",[51,65],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":31,"geoPoint":31,"contacts":59},"Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco","NOT_YET_RECRUITING","Alcaldía Coyoacán","Puebla","04530","Mexico","MX",[60],{"name":61,"role":42,"phone":62,"phoneExt":63,"email":64},"José Francisco González Dr.","55 74317715","+52","jf.gonzalezzamora@gmail.com",{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Clínica Viamed Montecanal","RECRUITING","Zaragoza","Aragon","50012","Spain","ES",{"type":74,"coordinates":75},"Point",[76,77],-0.87734,41.65606,{"lat":77,"lon":76},[80],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"type":82,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[84],{"name":85,"class":86},"Ministry of Science and Innovation, Spain","OTHER_GOV","100479566","effect-of-probiotics-on-infants-fecal-microbiota-composition-100479566",false,"NCT05524649","Effect of Probiotics on Infant's Fecal Microbiota Composition","Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants","BABYCARE","Inclusion Criteria:\n\n* Healthy infants\n* Age between 1 and 90 days\n* Gestational age between 37 and 42 weeks\n* Appropiate birth weight for gestational age (between P10 and P90)\n* APGAR test score for birth normal at 1' and 5' of 7-10\n* Whose parents accept the follow-up of the study procedures and sign the informed consent\n\nExclusion Criteria:\n\n* Infants participating in other clinical study\n* Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study\n* Infants who have taken antibiotics 4 weeks prior the start study\n* Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases\n* Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition\n* Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant\n* TORCH complex infections\n* Every other diseases related with the immune system\n* Parents who can not accomplish the follow-up of the study (medical criterium)",true,"ALL","1 Day","90 Days",{"count":100,"type":101},120,"ESTIMATED","INTERVENTIONAL",[104],"NA","Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.",[107],"Microbial Colonization",[109,110,111],"Probiotics","Infants","Microbiota","2025-02-10",{"date":114,"type":115},"2025-02-11","ACTUAL",{"date":117,"type":115},"2022-06-01",{"date":119,"type":101},"2025-12-31",{"name":5,"class":6},2]