[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637418":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University Hospital Olomouc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic supplement","ACTIVE_COMPARATOR",null,[13],"Dietary Supplement: A probiotic dietary supplement",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo group","PLACEBO_COMPARATOR",[18],"Dietary Supplement: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DIETARY_SUPPLEMENT","A probiotic dietary supplement","A probiotic dietary supplement containing a blend of probiotic bacteria from the Lactobacillaceae family, and the genera Streptococcus and Bifidobacterium, selected based on the latest knowledge concerning the use of probiotics in relation to GERD.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","placebo with the same appearance as the probiotic supplement",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Vít Navrátil, MUDr, Ph.D.","CONTACT","+420588445308","vit.navratil@fnol.cz",[36],{"facility":5,"status":37,"city":38,"state":11,"zip":39,"country":40,"countryCode":11,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Olomouc","77900","Czechia",{"type":42,"coordinates":43},"Point",[44,45],17.25175,49.59552,{"lat":45,"lon":44},[48],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[52],{"name":53,"class":6},"Masaryk University","100637418","early-phase-1-development-of-a-preparation-for-supportive-supplementation-of-probiotics-in-patients-with-reflux-100637418",false,"NCT07600008","Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux","Inclusion Criteria:\n\n* Diagnosed GERD.\n* Stable health without current complications.\n* Patients on stable pharmacological PPI therapy (rabeprazole).\n\nExclusion Criteria:\n\n* Use of probiotics or prebiotics within the last 4 weeks.\n* Pregnancy or breastfeeding.\n* Systemic antimicrobial therapy within the last 4 weeks.\n* Infectious disease of the respiratory or gastrointestinal tract within the last 2 weeks.\n* Serious chronic disease that could affect study results, including cancer, diabetes, inflammatory bowel disease, diagnosed SIBO.\n* Prior surgeries, especially fundoplication and resections of the esophagus or stomach.\n* Patients with psychiatric or cognitive disorders.\n* Hypersensitivity to components of the investigational product.","ALL","40 Years","55 Years",{"count":64,"type":65},50,"ESTIMATED","INTERVENTIONAL",[68],"EARLY_PHASE1","A two-arm, double-blind, randomized, placebo-controlled study investigating the efficacy of a probiotic preparation developed as supportive supplementation of probiotics in patients with reflux.\n\nThe objective of this trial is to evaluate the effect of the probiotic dietary supplement on the diversity and composition of the gut microbiome in patients diagnosed with GERD who are on PPI therapy. The study will also monitor changes in the oral microbiome and the impact of probiotic supplementation on patient quality of life and GERD symptoms.\n\nPatients will take the probiotic preparation, 2 tablets twice daily (morning before meals and evening after meals). The experimental phase will last 6 weeks. Patients in the control arm will receive placebo. Supplementation will be discontinued if adverse effects occur.\n\nOral and rectal swabs will be taken before and after administration of the preparation. Patients will monitor their symptoms using a questionnaire.",[71,72,73],"Reflux Disease","Microbiome","Probiotics Supplement","2026-05-17",{"date":76,"type":77},"2026-05-20","ACTUAL",{"date":79,"type":77},"2026-01-15",{"date":81,"type":65},"2026-07-30",{"name":5,"class":6},1]