[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476453":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":60,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":24,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Bari","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gastrus","EXPERIMENTAL","86 patients Gastrus sachets\u002Fchewable caps: 2x108 CFU Lactobacillus reuteri DSM 17938 + 2x108 CFU Lactobacillus reuteri ATCC PTA 6475.\n\nPlacebo sachets\u002Fchewable caps: Identical in shape, colour and taste to Gastrus capsules but without the Lactobacillus reuteri components.\n\nBoth study products are delivered in identical containers. Dosing: Two sachets\u002Fcps twice a day. Length of treatment: Gastrus or placebo will be administered for all the duration of PPI administration (8 weeks) plus two weeks after its discontinuation. A final evaluation will be performed 4 weeks after the discontinuation of both Gastrus and placebo.",[13],"Dietary Supplement: Gastrus",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475.\n\nGastrus will be administered for all the duration of PPI administration (8 weeks) plus two weeks after its discontinuation. A final evaluation will be performed 4 weeks after the discontinuation of both Gastrus.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"placebo has an identical preparation to Gastrus",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"ruggiero francavilla, professor","CONTACT","0805592847","ruggiero.francavilla@uniba.it",[35],{"facility":36,"status":37,"city":38,"state":24,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fernanda","RECRUITING","Bari","70100","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],16.86982,41.12066,{"lat":46,"lon":45},[49,52,53,56,58],{"name":50,"role":31,"phone":51,"phoneExt":24,"email":33},"ruggiero Francavilla, Professor","0805593580",{"name":30,"role":31,"phone":32,"phoneExt":24,"email":24},{"name":54,"role":55,"phone":24,"phoneExt":24,"email":24},"Fernanda cristofori, md","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":24,"phoneExt":24,"email":24},"vanessa nadia dargenio, md",{"name":59,"role":55,"phone":24,"phoneExt":24,"email":24},"stefania castellaneta, md",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Ruggiero Francavilla","Professor Ruggiero Francavilla","100476453","lactobacillus-reuteri-strain-combination-in-children-treated-with-ppi-100476453",false,"NCT05484128","Lactobacillus Reuteri Strain Combination in Children Treated With PPI","Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors","Inclusion Criteria:\n\n* Age: children between 1 month and 14 years of age;\n\n  o We start with children older than 4 years of age.\n* Necessity of therapy with Proton Pump Inhibitors for Gastroesophageal reflux disease and\u002For Functional Dyspepsia;\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Neurological pathologies (PCI and Spastic tetra-paresis);\n* Nasogastric feeding;\n* Known immunodeficiency;\n* Previous therapy with gastric acid inhibitors;\n* HP infection;\n* Assumption of prebiotics, other probiotics or symbiotics in the previous month;\n* Malnutrition or severe dystrophy;\n* Cystic Fibrosis.","ALL","12 Months","14 Years",{"count":75,"type":76},172,"ESTIMATED","INTERVENTIONAL",[79],"NA","Probiotics might be of help in preventing dysbiosis and emergence of SIBO. Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475; the first have extensive data supporting its use in gastric infections (18) however, it lacks the anti-inflammatory properties that have been provided by L. Reuteri DSM ATCC PTA 6475 that has excellent acid resistance and has strong anti-inflammatory properties (19); for these reasons, Gastrus is the best candidate for this indication.",[82,83,84],"Gastric Lesion","Proton Pump Inhibitor Adverse Reaction","Probiotic",[86,87,88,89],"Reuteri","Proton Pump Inhibitor","gastrus","infections","2024-12-03",{"date":92,"type":93},"2024-12-05","ACTUAL",{"date":95,"type":93},"2020-03-04",{"date":97,"type":76},"2025-12-31",{"name":5,"class":6},1]