[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448559":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":37,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Hospital Freiburg","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Helicobacter pylori patients",null,"Patients with gastric biposies which was positive for Helicobacter pylori in culture",[13],"Diagnostic Test: Analysis of gut microbiome and immune signatures",{"label":15,"type":10,"description":16,"interventionNames":17},"Helicobacter pylori asymptomatic carriers","Healthy controls who are positive for Helicobacter pylori antigen in stool and have no symptoms of gastritis",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Healthy controls","Healthy controls who are negative for Helicobacter pylori antigen in stool and have no symptoms of gastritis",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Analysis of gut microbiome and immune signatures","The investigators will analyse the microbiome composition (16S rDNA-sequencing and metagenomics), microbiome activity (RNA-sequencing of stool bacteria and metabolite sampling) and immune cell activity (leukocyte RNA-sequencing) of all study groups.",[19,15,9],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Mohamed Tarek Badr, M.D.","CONTACT","00497612036585","mohamed.tarek.badr@uniklinik-freiburg.de",{"name":35,"role":31,"phone":32,"phoneExt":10,"email":36},"Anne Lichtenegger","anne.sophie.lichtenegger@uniklinik-freiburg.de",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Institute for Microbiology and Hygiene","RECRUITING","Freiburg im Breisgau","Baden-Wurttemberg","79104","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],7.85222,47.9959,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":10,"phoneExt":10,"email":10},"Mohamed Tarek Badr, MD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Mohamed Tarek Badr","Principal Investigator","100448559","pathogen-microbiome-interaction-during-helicobacter-pylori-infection-100448559",false,"NCT05121025","Pathogen-microbiome Interaction During Helicobacter Pylori Infection","Pathogen-microbiome Interaction in Human Response and Disease-outcome During Infection and Colonization With Helicobacter Pylori","PREDICTHP","Inclusion Criteria:\n\nPatients: -\n\n* Male and female patients aged ≥ 18 years.\n* Specimens from patients undergoing tissue sampling, stool, and blood to rule out Helicobacter pylori infection\n* Written informed consent from patients.\n\nVolunteer subjects: -\n\n* Male and female (non-pregnant) volunteers between the ages of 18-65 years.\n* Written informed consent from volunteers.\n* No acute medical conditions\n* No regular medication use, and no antibiotic use in the last 4 weeks.\n\nExclusion Criteria:\n\nPatients: -\n\n* Minor patients\n* Patients not capable of giving consent\n* Samples without sufficient residual material after standard diagnostic procedures\n* Samples from patients who have not given consent for testing\n\nVolunteer subjects: -\n\n* Subjects not capable of giving consent\n* Subjects with acute illnesses\n* Subjects older than 65 or younger than 18 years of age.\n* Pregnant women",true,"ALL","18 Years",{"count":71,"type":72},180,"ESTIMATED","OBSERVATIONAL","Helicobacter pylori affects the gut microbiome in ways that are only partially understood. In which patients H. pylori causes severe disease and in whom it merely colonizes, possibly even with beneficial effects, is not understood. The investigators are pursuing the hypothesis that changes in the gut microbiome that can be easily measured in stool have such predictive value.",[76],"Helicobacter Pylori Infection",[78,79],"Helicobacter Pylori","Metagenomics","2024-12-04",{"date":82,"type":83},"2024-12-05","ACTUAL",{"date":85,"type":83},"2022-03-11",{"date":87,"type":72},"2025-12-30",{"name":5,"class":6},1]