[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gala Servicios Clinicos S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Helicobacter Pylori Infection","Dyspepsia","Gastrointestinal Adverse Effects",[31,32,33,34,35,36,37,38,39,40],"Helicobacter pylori","H. pylori infection","Pylori Duo","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":44,"type":45},"2026-07-27","ACTUAL",{"date":47,"type":21},"2026-08-31",{"date":49,"type":21},"2028-09-30",{"name":51,"class":52},"Gala Servicios Clinicos S.L.","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100647991","enzymax-duobiotics-for-irritable-bowel-syndrome-100647991","NCT07716852","Enzymax DuoBiotics for Irritable Bowel Syndrome","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of Enzymax DuoBiotics in Adults With Irritable Bowel Syndrome","ENZYMAX-IBS","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Diagnosis of irritable bowel syndrome according to the Rome IV criteria.\n* Presence of active irritable bowel syndrome symptoms at the time of enrollment.\n* Ability and willingness to provide written informed consent.\n* Ability and willingness to comply with the study procedures and the 12-week treatment period.\n\nExclusion Criteria:\n\n* Presence of an organic gastrointestinal disease.\n* Use of antibiotics or probiotics within 1 month before enrollment.\n* Recent clinically relevant changes in diet.\n* Severe comorbid medical conditions.\n* Inability or unwillingness to comply with the study protocol.\n* Known hypersensitivity to any component of Enzymax DuoBiotics or to dietary supplements of similar composition.\n* Any other condition that, in the investigator's judgment, may interfere with participation, study treatment, or interpretation of the results.",{"count":63,"type":21},120,[24],"Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits in the absence of detectable structural abnormalities. Its pathophysiology is multifactorial and may involve alterations in the intestinal microbiota, impaired epithelial barrier function, low-grade immune activation, and disturbances in the digestion and fermentation of dietary nutrients.\n\nEnzymax DuoBiotics combines digestive enzymes with a synbiotic formulation in a capsule-in-capsule delivery system. The outer capsule contains digestive enzymes intended for release in the stomach, whereas the inner capsule contains Lactobacillus plantarum and fructooligosaccharides intended for release in the intestine. This formulation is designed to separate the enzymatic and synbiotic components and support their delivery to the intended gastrointestinal sites. The combined approach is intended to support macronutrient digestion while modulating the intestinal microbial environment.\n\nThis randomized, double-blind, placebo-controlled, parallel-group study will compare once-daily Enzymax DuoBiotics with placebo over a 12-week treatment period in adults with IBS. Participants will be allocated in a 1:1 ratio, and treatment effects over time will be evaluated using assessments performed during the treatment period. The primary statistical analysis will use linear mixed-effects models including treatment group, time, and the treatment group-by-time interaction. The primary analysis will follow the intention-to-treat principle and may be supplemented by a per-protocol analysis.",[67,68],"Irritable Bowel Syndrome","Irritable Bowel Syndrome (IBS)",[70,71,72,35,73,74,75,76,77,78],"Irritable bowel syndrome","IBS","Enzymax DuoBiotics","Synbiotic","Lactobacillus plantarum","Fructooligosaccharides","Digestive enzymes","Gastrointestinal symptoms","Gut microbiota","2026-07-22",{"date":81,"type":45},"2026-07-23",{"date":83,"type":21},"2026-09-30",{"date":85,"type":21},"2027-09-30",{"name":51,"class":52},""]