[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649053":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":47,"locations":54,"responsibleParty":68,"collaborators":28,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":28,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":28,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":101,"whyStopped":28,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Gala Servicios Clinicos S.L.","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Quadruple Therapy + Placebo","PLACEBO_COMPARATOR","Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days during Phase I, followed by placebo for 3 months during Phase II.",[13,14,15],"Drug: Omeprazole","Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole","Other: Placebo",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard Quadruple Therapy + Pylori Duo","EXPERIMENTAL","Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with Pylori Duo for 10 days during Phase I, followed by Pylori Duo for 3 months during Phase II.",[13,14,21],"Dietary Supplement: Pylori Duo",[23,29,33,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Omeprazole","Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.",[9,17],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole","Pylera® will be administered in combination with omeprazole as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.",[9,17],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"DIETARY_SUPPLEMENT","Pylori Duo","Pylori Duo is a dietary supplement containing Lactobacillus rhamnosus and dried licorice extract. Participants assigned to the experimental arm will receive Pylori Duo in combination with standard quadruple therapy for 10 days, followed by Pylori Duo for 3 months during the post-treatment phase.",[17],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Placebo","Placebo capsules identical in appearance to Pylori Duo, but without pharmacologically active ingredients, will be administered in combination with standard quadruple therapy for 10 days, followed by placebo for 3 months during the post-treatment phase.",[9],[43],{"name":44,"affiliation":45,"role":46},"Sergio Chamorro Benítez, Medicine","Hospital Parque Vegas Altas, Don Benito (Badajoz)","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Juan Antonio Carrillo, Medicine","CONTACT","647725527","+34","carrillo@unex.es",[55],{"facility":56,"status":28,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":28},"GALA Laboratories","Don Benito","Badajoz","06400","Spain","ES",{"type":63,"coordinates":64},"Point",[65,66],-5.86162,38.95627,{"lat":66,"lon":65},{"type":69,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100649053","pylori-duo-for-adjunctive-treatment-and-prevention-of-recurrence-of-helicobacter-pylori-infection-100649053",false,"NCT07729293","Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection","A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pylori Duo as an Adjunctive Treatment and for the Prevention of Recurrence of Helicobacter Pylori Infection","Inclusion Criteria:\n\n* Adults aged 18 to 70 years.\n* Confirmed Helicobacter pylori infection prior to treatment, as determined by a positive 13C-urea breath test (13C-UBT) and gastric biopsy.\n* No previous H. pylori eradication therapy.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Significant underlying conditions that, in the opinion of the treating physician, would preclude participation in the study, including hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase \\>3 times the upper limit of normal), renal insufficiency (creatinine ≥2.0 mg\u002FdL or glomerular filtration rate \\\u003C50 mL\u002Fmin), immunosuppression, malignant tumors, coronary heart disease or coronary artery stenosis ≥75%, thyroid disease, pulmonary disease, or any other serious medical condition.\n* Pregnancy, breastfeeding, or unwillingness to use contraception during the study.\n* Active gastrointestinal bleeding.\n* History of upper gastrointestinal tract surgery.\n* History of allergic reactions to medications included in the treatment regimen.\n* Use of bismuth-containing agents, antibiotics, proton pump inhibitors, or other relevant medications within 4 weeks prior to treatment.\n* Behaviors that may increase the risk of illness, including excessive alcohol consumption or substance abuse.\n* Negative repeat urea breath test prior to treatment initiation.\n* Unwillingness or inability to provide informed consent.","ALL","18 Years","70 Years",{"count":81,"type":82},140,"ESTIMATED","INTERVENTIONAL",[85],"NA","This randomized, double-blind, placebo-controlled, single-center clinical trial will evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 participants will be randomized to receive standard quadruple therapy (omeprazole plus Pylera®) combined with either placebo or Pylori Duo for 10 days, followed by placebo or Pylori Duo for 3 months. The primary objective is to assess the effect of Pylori Duo on gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include assessment of H. pylori eradication, recurrence at 3 and 12 months, gastrointestinal symptoms, quality of life, and safety.",[88,89,90],"Helicobacter Pylori Infection","Dyspepsia","Gastrointestinal Adverse Effects",[92,93,35,94,95,96,97,98,99,100],"Helicobacter pylori","H. pylori infection","Adjunctive treatment","Dietary supplement","Eradication therapy","Gastrointestinal adverse effects","Placebo-controlled trial","13C-urea breath test","Recurrence prevention","NOT_YET_RECRUITING","2026-07-24",{"date":104,"type":105},"2026-07-27","ACTUAL",{"date":107,"type":82},"2026-08-31",{"date":109,"type":82},"2028-09-30",{"name":5,"class":6},1]