[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658447":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":42,"studyPopulation":42,"armGroups":46,"interventions":59,"overallOfficials":42,"centralContacts":70,"locations":76,"responsibleParty":92,"collaborators":42,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":42,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":42,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":120,"whyStopped":42,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Federal State Budgetary Scientific Institution","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Change in gut microbiota beta diversity","Gut microbiota beta diversity will be assessed using distance-based measures derived from 16S rRNA gene sequencing of stool samples, including Bray-Curtis dissimilarity and phylogenetic UniFrac distances.","Baseline and Day 14",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Change in Shannon diversity index","Change in gut microbiota alpha diversity assessed using the Shannon diversity index derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater microbial diversity.",{"measure":18,"description":19,"timeFrame":12},"Change in Simpson diversity index","Change in gut microbiota alpha diversity assessed using the Simpson diversity index derived from 16S rRNA gene sequencing of stool samples. Values range from 0 to 1, with higher values indicating greater microbial diversity.",{"measure":21,"description":22,"timeFrame":12},"Change in Chao1 richness estimator","Change in gut microbiota richness assessed using the Chao1 richness estimator derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater estimated microbial richness.",{"measure":24,"description":25,"timeFrame":12},"Change in modified Frequency Scale for the Symptoms of GERD total score","Change in the total modified Frequency Scale for the Symptoms of GERD (mFSSG) score from baseline to Day 14. The questionnaire includes 14 items scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more frequent GERD-related symptoms.",{"measure":27,"description":28,"timeFrame":12},"Change in high-sensitivity C-reactive protein concentration","Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration.",{"measure":30,"description":31,"timeFrame":12},"Change in systemic immune-inflammation index","Change in the systemic immune-inflammation index (SII), calculated as platelet count × neutrophil count \u002F lymphocyte count.",[33,36],{"measure":34,"description":35,"timeFrame":12},"Change in oral microbiota composition","Changes in oral microbiota composition will be assessed using microbiome analysis of saliva samples, including measures of microbial diversity and taxonomic composition.",{"measure":37,"description":38,"timeFrame":12},"Change in serum lipopolysaccharide-binding protein concentration","Change in serum lipopolysaccharide-binding protein (LBP) concentration from baseline to Day 14.",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":42,"timePerspective":42,"maskingInfo":44},"RANDOMIZED","PARALLEL",null,"BASIC_SCIENCE",{"masking":45,"maskingDescription":42,"whoMasked":42},"NONE",[47,54],{"label":48,"type":49,"description":50,"interventionNames":51},"Omeprazole Plus Standard Non-pharmacological Recommendations","EXPERIMENTAL","Participants will receive omeprazole 20 mg orally once daily for 14 days in addition to standard non-pharmacological recommendations for gastroesophageal reflux disease.",[52,53],"Drug: Omeprazole","Behavioral: Standard Non-pharmacological Recommendations for GERD",{"label":55,"type":56,"description":57,"interventionNames":58},"Standard Non-pharmacological Recommendations","ACTIVE_COMPARATOR","Participants will receive standard non-pharmacological recommendations for gastroesophageal reflux disease for 14 days.",[53],[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":42},"DRUG","Omeprazole","Omeprazole 20 mg administered orally once daily for 14 days.",[48],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":42},"BEHAVIORAL","Standard Non-pharmacological Recommendations for GERD","Standard non-pharmacological recommendations for gastroesophageal reflux disease management.",[48,55],[71],{"name":72,"role":73,"phone":74,"phoneExt":42,"email":75},"Georgy E. Leonov, MD, PhD","CONTACT","+7 9055687783","golerus@gmail.com",[77],{"facility":78,"status":42,"city":79,"state":42,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Federal Research Centre of Nutrition, Biotechnology and Food Safety","Moscow","115446","Russia","RU",{"type":84,"coordinates":85},"Point",[86,87],37.61781,55.75204,{"lat":87,"lon":86},[90],{"name":91,"role":73,"phone":74,"phoneExt":42,"email":75},"Georgy Leonov, MD, PhD",{"type":93,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100658447","phase-4-effect-of-omeprazole-on-gut-microbiota-in-adults-with-obesity-and-gerd-100658447",false,"NCT07850960","Effect of Omeprazole on Gut Microbiota in Adults With Obesity and GERD","Effect of Proton Pump Inhibitors on Gut Microbiota Composition in Adults With Obesity and Gastroesophageal Reflux Disease","Inclusion Criteria:\n\n* Age 50 to 65 years, inclusive.\n* Obesity, defined as body mass index (BMI) ≥30 kg\u002Fm².\n* Symptomatic gastroesophageal reflux disease with mild or moderate typical symptoms, including heartburn and\u002For regurgitation.\n* For female participants, postmenopausal status, defined as absence of menstruation for at least 12 months without another apparent cause of amenorrhea.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe or exacerbated GERD, or GERD requiring acid-suppressive therapy or additional diagnostic evaluation.\n* Use of proton pump inhibitors or histamine H2-receptor antagonists within 8 weeks prior to enrollment.\n* Use of systemic antibiotics within 3 months prior to enrollment.\n* Use of probiotic or synbiotic supplements within 8 weeks prior to enrollment.\n* Inflammatory bowel disease, celiac disease, or other severe chronic gastrointestinal disorders that may substantially affect the gut microbiota.\n* History of bariatric surgery or other major gastrointestinal surgery.\n* Acute infectious or inflammatory disease at enrollment.\n* History of myocardial infarction or stroke.\n* Type 2 diabetes mellitus.\n* Chronic heart failure, New York Heart Association functional class III-IV.\n* Chronic kidney disease with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m².\n* Alcohol dependence or other substance use disorder.\n* Severe psychiatric disorder or cognitive impairment that may interfere with providing informed consent or adherence to the study protocol.\n* Known hypersensitivity or contraindications to omeprazole.","ALL","50 Years","65 Years",{"count":105,"type":106},26,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","This randomized, open-label, parallel-group study will evaluate the effect of short-term omeprazole therapy on gut and oral microbiota in adults aged 50-65 years with obesity and symptomatic gastroesophageal reflux disease. Participants will be randomized 1:1 to receive omeprazole 20 mg once daily for 14 days plus standard non-pharmacological recommendations for gastroesophageal reflux disease, or standard non-pharmacological recommendations alone. Clinical and laboratory assessments will be performed at baseline and after 14 days. Stool and saliva samples will be collected to assess gut and oral microbiota, and blood samples will be collected for laboratory biomarkers.",[112,113],"Obesity & Overweight","Gastroesophageal Reflux Disease",[115,116,62,117,118,119],"Gut Microbiota","Oral Microbiota","Proton Pump Inhibitors","GERD","16S rRNA Sequencing","NOT_YET_RECRUITING","2026-09-24",{"date":123,"type":124},"2026-10-01","ACTUAL",{"date":126,"type":106},"2026-09-25",{"date":128,"type":106},"2026-12-25",{"name":5,"class":6},1]