[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"less-than-3-months-old\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:less-than-3-months-old":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100631795","an-intervention-study-in-healthy-infants-aged-0-6-months-with-probiotics-lacticaseibacillus-rhamnosus-lra05-lra05-and-bifidobacterium-animalis-subsp-lactis-bla80-bla80-vs-placebo-for-promoting-gut-microbiome-development-100631795",false,"NCT07505329","An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development.","SMILE","Inclusion criteria Written (electronic) informed consent provided by parent to allow their infant to participate in the study.\n\nNo antibiotic use since birth. Infant not to be taking any medications. Infant not to be taking probiotics. Breastfed or formula fed until weaning. Infants born via c-section or vaginally. Healthy male and female infants.\n\nExclusion criteria Infant is older than 3 months at the time their first study visit (Baseline visit).\n\nInfants who have a known diagnosis of inflammatory bowel disease or another medical condition.\n\nInfants with complex medical or behavioural needs that would deem the infant unable to participate in the study.\n\nHave a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates entry to the study according to the investigator's judgement.\n\nInfants who are receiving treatment involving experimental medications. Have a malignant disease or any concomitant end-stage organ disease. Infants born before 37 weeks of pregnancy.",true,"ALL","1 Month","3 Months",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","The probiotics Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 have potential to enhance infant health and development based on previous research conducted on human infants.\n\nBifidobacterium animalis subsp. lactis BLa80 was isolated from healthy breast milk samples.\n\nTen clinical studies have been conducted using this strain, including randomized, double-blind, placebo-controlled trials, involving over 700 clinical subjects, adults and children. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of constipation, improved sleep quality, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, gestational diabetes management and emotional management.\n\nLacticaseibacillus rhamnosus LRa05 was isolated from healthy baby faeces. Six clinical studies have been conducted, involving randomized, double-blind, placebo-controlled studies using this strain, involving over 500 clinical subjects. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of eczema, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, and gestational diabetes management.\n\nThis proposal describes a three-year collaboration with APC Microbiome Ireland, INFANT Research Centre and WeCare to conduct clinical studies to investigate the effects of probiotics (Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa050), compared to a placebo, on the growth of infants and toddlers and the development of their gut microbiota. The focus of this study is on infant growth and gut microbiota development in infants up to 6 months old.",[28,29],"Less Than 3 Months Old","Healthy Infants",[31,32,33],"Gut microbiome","Oral probiotics","Healthy infants","NOT_YET_RECRUITING","2026-03-26",{"date":37,"type":38},"2026-04-01","ACTUAL",{"date":40,"type":22},"2026-04",{"date":42,"type":22},"2028-03",{"name":44,"class":45},"University College Cork","OTHER"]