[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612447":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":28,"responsibleParty":116,"collaborators":10,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":10,"studyType":133,"phases":10,"briefSummary":134,"conditions":135,"keywords":141,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients",null,"Age 2-79 years, newly diagnosed with epilepsy, treatment-naive at time of enrollment. Exclusion criteria: already started ASM treatment (more then one dose), has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy",{"label":13,"type":10,"description":14,"interventionNames":10},"Controls","Age 2-79 years, exclusion criteria: previous epilepsy diagnosis or ASM treatment, has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy",[16],{"name":17,"affiliation":5,"role":18},"Stefanie Prast-Nielsen, PhD","STUDY_DIRECTOR",[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Ronny Wickström, MD, PhD","CONTACT","+46 70 68 38 182","ronny.wickstrom@ki.se",{"name":17,"role":22,"phone":26,"phoneExt":10,"email":27},"+46 76 21 67 781","stefanie.prast-nielsen@ki.se",[29,46,59,72,90,103],{"facility":30,"status":31,"city":32,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Drottning Silvias Barnsjukhus","RECRUITING","Gothenburg","Sweden","SE",{"type":36,"coordinates":37},"Point",[38,39],11.96679,57.70716,{"lat":39,"lon":38},[42],{"name":43,"role":22,"phone":44,"phoneExt":10,"email":45},"Ann-Louise Esserlind, MD","+46 31 343 63 00","ann-louise.esserlind@vgregion.se",{"facility":47,"status":31,"city":48,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Universitetssjukhuset i Linköping","Linköping",{"type":36,"coordinates":50},[51,52],15.62157,58.41086,{"lat":52,"lon":51},[55],{"name":56,"role":22,"phone":57,"phoneExt":10,"email":58},"Helena Gauffin, MD","+46 10 103 00 00","Helena.Gauffin@regionostergotland.se",{"facility":60,"status":31,"city":61,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Skånes universitetssjukhus","Lund",{"type":36,"coordinates":63},[64,65],13.19321,55.70584,{"lat":65,"lon":64},[68],{"name":69,"role":22,"phone":70,"phoneExt":10,"email":71},"Erik Eklund, MD","+46 46 17 85 00","Erik.Eklund@skane.se",{"facility":73,"status":31,"city":74,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Karolinska Universitetssjukhus","Stockholm",{"type":36,"coordinates":76},[77,78],18.06871,59.32938,{"lat":78,"lon":77},[81,85,88],{"name":82,"role":22,"phone":83,"phoneExt":10,"email":84},"Sigrid Bjuresäter, Registered nurse","+46 8 123 774 61","sigrid.bjuresater@ki.se",{"name":86,"role":22,"phone":87,"phoneExt":10,"email":24},"Ronny Wickström, MD","+46 8 123 706 27",{"name":86,"role":89,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":91,"status":31,"city":92,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Norrlands universitetssjukhus","Umeå",{"type":36,"coordinates":94},[95,96],20.25972,63.82842,{"lat":96,"lon":95},[99],{"name":100,"role":22,"phone":101,"phoneExt":10,"email":102},"Måns Berglund, MD","+46 90 785 91 40","mans.berglund@regionvasterbotten.se",{"facility":104,"status":31,"city":105,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Akademiska Sjukhuset","Uppsala",{"type":36,"coordinates":107},[108,109],17.63889,59.85882,{"lat":109,"lon":108},[112],{"name":113,"role":22,"phone":114,"phoneExt":10,"email":115},"Christian Wentzel, MD","+46 18 611 58 48","christian.wentzel@uu.se",{"type":89,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Stefanie P rast-Nielsen","Associate Professor","100612447","epigut-epilepsy-and-gastrointestinal-microbiota-understanding-therapy-response-100612447",false,"NCT07253701","EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE","EpiGUT","Inclusion Criteria:\n\n* Patients: Age 2-79 years, newly diagnosed with epilepsy, treatment-naive at time of enrollment\n* Controls: Age 2-79 years\n\nExclusion Criteria:\n\n* Patients: already started ASM treatment (more then one dose), has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy\n* Controls: previous epilepsy diagnosis or ASM treatment, has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy",true,"ALL","2 Years","79 Years",{"count":131,"type":132},1500,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how the bacteria in the gut and mouth (called the microbiota) are linked to different types of epilepsy and how they may affect how well seizure medicines work.\n\nResearchers want to answer two main questions:\n\nAre certain types of epilepsy linked to changes in the gut or mouth microbiota? Do the bacteria in the gut change how seizure medicines work for each person?\n\nEpilepsy is a brain condition that causes seizures. Even though there are many medicines for epilepsy, some people still have seizures or side effects. Studies in animals show that gut bacteria can raise or lower the chance of seizures. Smaller studies in people suggest the same thing, but they have been limited in size and scope.\n\nIn this study, researchers will collect biological samples from people who have newly diagnosed epilepsy and from people without epilepsy (called healthy controls). The samples will be tested to learn which bacteria are present. The researchers will then look for patterns that may explain which types of epilepsy are linked to changes in the microbiota.\n\nThe study will also look at whether the bacteria in the gut and mouth affect how well anti-seizure medicines (ASMs) work. For example, the researchers will explore if certain bacteria make medicines work better or worse.\n\nPatients will provide blood, stool and saliva samples. If collected for medical reasons, cerebrospinal fluid (CSF) - the clear liquid that surrounds the brain and spinal cord -will also be used.\n\nHealthy controls will provide stool and saliva samples only\n\nAll participants will be asked to fill an online questionnaire to share health and lifestyle information.\n\nPatients also allow researchers to confidentially access data from medical records related to diagnosis and treatment.\n\nBy comparing data from many participants across Sweden, researchers hope to understand how gut and mouth bacteria influence epilepsy and seizure control.\n\nThis research may help doctors in the future to use a person's microbiota profile to choose the best seizure medicine. The long-term goal is to improve seizure control, reduce side effects, and raise the quality of life for people living with epilepsy.",[136,137,138,139,140],"Epilepsy","Microbiota","Proteomics","Metabolomics","Biomarker Discovery",[142,143,144,145,146],"seizures","microbiome","anti-seizure medication","gut-brain-axis","epilepsy","2025-11-19",{"date":149,"type":150},"2025-11-28","ACTUAL",{"date":152,"type":150},"2024-02-27",{"date":154,"type":132},"2028-03",{"name":5,"class":6},6]