[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626772":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":46,"collaborators":26,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"University College Dublin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic drink","EXPERIMENTAL","Encapsulated Lacticaseibacillus rhamnosus in 200 ml Yogurt drink",[13],"Biological: probiotic containing L.rhamnosus R0011 strain",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo drink","PLACEBO_COMPARATOR","200 ml yogurt drink",[19],"Dietary Supplement: 200 ml yogurt drink",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","probiotic containing L.rhamnosus R0011 strain","Twenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose of 200 ml on two different occasions for 28 days, a commercial dairy drink fortified with 1Billion probiotics in the pea protein capsules. Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline.",[9],null,{"type":28,"name":17,"description":29,"armGroupLabels":30,"otherNames":26},"DIETARY_SUPPLEMENT","Twenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose 200 ml on two different occasions for 28 days, a commercial dairy drink (no probiotics). Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline.",[15],[32],{"name":33,"affiliation":34,"role":35},"Carel Le Roux, PhD","St Vincent's University Hospital, Ireland","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Werd Al-Najim, PhD","CONTACT","+353 0864117842","werd.al-najim@ucd.ie",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Ahmed Al-Humadi, PhD","+353 083 0994008","ahmed.al-humadi@ucd.ie",{"type":47,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100626772","phase-1-encapsulated-probiotics--gut-microbiota-100626772",false,"NCT07439978","Encapsulated Probiotics & Gut Microbiota","A Physiological Study of a Fermented Yogurt Drink Containing Probiotics","Probiotics","Inclusion Criteria:\n\n* Capacity to obtain and sign informed consent before any study-related procedure\n* BMI range 18.5-31.9 kg\u002Fm2\n* Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages).\n* Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded:\n\n* Smoking\n* Substance abuse\n* Pregnancy\n* Diagnosis of type 1 and\u002For type 2 diabetes\n* Current (or within the last 4 weeks prior to study start) use of probiotic supplementation.\n* Immobile (defined as the inability to participate in all study-related procedures)\n* History of complicated gastrointestinal surgery\n* Diagnosed with inflammatory bowel disease (IBD)\n* Current diagnosis of psychiatric disease\u002Fs or syndromes\n* Current diagnosis of neurodegenerative disease\n* Systemic use of antibiotics and\u002For steroid medication in the last 4 months prior to inclusion\n* Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months\n* Consumption of any NSAID within 7 days of study start\n* Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) or in any other way with the outcome of the study, as decided by the principal investigator's discretion\n* Regular smoking, use of snuff, nicotine, cannabidiol narcotics\u002Fsupplements, or e-cigarette use\n* Drinking more than 9 standard cups of alcohol per week and\u002For more than 3 standard cups of alcohol per occasion\n* Regular use, for more than three times a week for the last 2 months and\u002For 7 days prior to inclusion, of medications which, according to the principal investigator, can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)\n* After being included in the study, starting any medication or treatment that could potentially influence the study participation and\u002For study analysis.",true,"ALL","25 Years","65 Years",{"count":61,"type":62},50,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","The aim of this study is to determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function.\n\nTwenty-five participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the blood and faecal effects of a 28-day ingestion of a yoghurt beverage with and without the probiotic strain of interest. The study window will be 70+\u002F13 days.\n\nThe current study will provide important information on the physiological function of probiotics in the small bowel. Understanding the underlying physiological effects of targeted probiotic delivery to the intestine and the impact on the microbiome is important for health outcomes.",[68,69],"Colonization, Asymptomatic","Colonisation",[71,72,73,74],"Probiotic","Microbiota","Colonization","Dairy","NOT_YET_RECRUITING","2026-05-05",{"date":78,"type":79},"2026-05-08","ACTUAL",{"date":81,"type":62},"2026-04",{"date":83,"type":62},"2026-08",{"name":5,"class":6}]