[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640622":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":38,"responsibleParty":92,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":26,"enrollmentInfo":107,"targetDuration":26,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":120,"whyStopped":26,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Haukeland University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychotherapy treatment as usual (TAU)","ACTIVE_COMPARATOR","The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU)",[13],"Other: Psychotherapy treatment as usual (TAU)",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients receiving TAU in combination with FMT","EXPERIMENTAL","The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU) in combination with a single dose fecal microbiota transplantation (FMT)",[19],"Biological: Psychotherapy as usual combined with single dose normal gut microbiota",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Psychotherapy as usual combined with single dose normal gut microbiota","Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU",[15],null,{"type":6,"name":9,"description":9,"armGroupLabels":28,"otherNames":26},[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Stein Frostad, MD PhD","CONTACT","+47 95003257","stein.frostad@helse-bergen.no",{"name":36,"role":32,"phone":26,"phoneExt":26,"email":37},"Olivia B Helland, Master of Science","olivia.bysheim.helland@helse-bergen.no",[39,55,69,78],{"facility":40,"status":26,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Haugalandet distriktspsykiatriske senter","Haugesund","5535","Norway","NO",{"type":46,"coordinates":47},"Point",[48,49],5.268,59.41378,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":26,"phoneExt":26,"email":54},"Kenneth Eikeset, MD","kenneth.eikeset@helse-fonna.no",{"facility":56,"status":26,"city":57,"state":58,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Helse Møre og Romsdal","Ålesund","Møre og Romsdal","6026",{"type":46,"coordinates":61},[62,63],6.15492,62.47225,{"lat":63,"lon":62},[66],{"name":67,"role":32,"phone":26,"phoneExt":26,"email":68},"Dag AL Hoff, MD PhD","Dag.Arne.Lihaug.Hoff@helse-mr.no",{"facility":70,"status":26,"city":71,"state":43,"zip":72,"country":43,"countryCode":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":26},"Haukeland University Hospital in Helse Bergen","Bergen","5096",{"type":46,"coordinates":74},[75,76],5.32415,60.39299,{"lat":76,"lon":75},{"facility":79,"status":26,"city":80,"state":81,"zip":82,"country":43,"countryCode":44,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Sola distriktspsykiatriske senter","Stavanger","Sola","4050",{"type":46,"coordinates":84},[85,86],5.73332,58.97005,{"lat":86,"lon":85},[89],{"name":90,"role":32,"phone":26,"phoneExt":26,"email":91},"Øystein Enger, Specialist Clinical Psychology","oystein.enger@sus.no",{"type":93,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[95],{"name":96,"class":6},"The Dam Foundation","100640622","phase-1-reestablishing-normal-gut-brain-interaction-in-anorexia-nervose-with-normal-gut-microbiota-100640622",false,"NCT07574892","Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota","Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart","Restart","Inclusion Criteria:\n\nAge 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt\n\nExclusion Criteria:\n\nAge below 18 years BMI below 16 kg\u002Fm2 Significant electrolyte disturbances Other signs of medical instability Presence of systemic disease, Immune deficiency Treated with immune-modulating medication Pregnancy Planning pregnancy Lactations Having undergone abdominal surgery (with the exception of appendectomy, cholecystectomy, caesarian section and hysterectomy) severe psychiatric disease (except anorexia nervosa) Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry.","FEMALE","18 Years",{"count":108,"type":109},36,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","In this pilot study 36 patients with anorexia nervosa (AN) will be randomized to either treatment with psychotherapy as usual (TAU) or TAU plus fecal microbiota transplantation (FMT). The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.",[115],"Anorexia Nervosa",[117,118,119],"Anorexia nervosa","Fecal microbiota transplantation","Psychotherapy","NOT_YET_RECRUITING","2026-05-05",{"date":123,"type":124},"2026-05-08","ACTUAL",{"date":126,"type":109},"2026-06-01",{"date":128,"type":109},"2028-12",{"name":5,"class":6},4]