[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590740":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Biofeedback","EXPERIMENTAL","Three biofeedback sessions will be administered during the first three weeks of the intervention period. In each session, participants will receive a standardized meal and undergo training to control abdominal and thoracic muscular activity. This training will be guided by a trained operator using original audiovisual materials and hands-on techniques. Regurgitation episodes will be recorded by participants using an event marker. Following each session, participants will be instructed to perform the same exercises before and after breakfast, lunch, and dinner throughout the four-week intervention period.",[13],"Behavioral: Biofeedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Three treatment sessions will be conducted during the first three weeks of the intervention period. In each session, participants will receive a placebo capsule prior to a standardized meal and will be instructed to record the number of regurgitation episodes using an event marker. Following each session, participants will be asked to take a placebo capsule before each meal throughout the four-week intervention period.",[19],"Dietary Supplement: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Three sessions of biofeedback before and after a standardized meal.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"DIETARY_SUPPLEMENT","Three sessions of placebo followed by standardized meal.",[15],[31],{"name":32,"affiliation":33,"role":34},"Jordi Serra, M.D.","Vall d'Hebron Research Institute, Barcelona, 08035","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","34 93 274 6259","jordiserra@vallhebron.cat",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Gloria Santaliestra","34 932746259","gloria.santaliestra@vhir.org",[45],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Vall d'Hebron Research Institute","RECRUITING","Barcelona","08035","Spain","ES",{"type":53,"coordinates":54},"Point",[55,56],2.15899,41.38879,{"lat":56,"lon":55},[59],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":60},"jordi.serra@vallhebron.cat",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100590740","treatment-of-rumination-100590740",false,"NCT06971354","Treatment of Rumination","Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado","Inclusion Criteria:\n\n* Rumination syndrome\n\nExclusion Criteria:\n\n* Relevant organic diseases","ALL","18 Years","75 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","Background: Rumination syndrome is characterized by the involuntary regurgitation of previously ingested food from the stomach to the mouth, triggered by an unintentional contraction of the abdominal muscles along with simultaneous relaxation of the esophageal sphincters. Based on this mechanism, a biofeedback technique targeting muscular activity has been developed and shown to be effective. However, such techniques are often complex and not widely accessible.\n\nHypothesis: Rumination can be effectively treated using a simplified, non-instrumental biofeedback technique based on cognitive intervention.\n\nObjective: To evaluate the effectiveness of a non-instrumental biofeedback technique incorporating cognitive intervention for the treatment of rumination. The methodology will build on prior studies, employing a more streamlined biofeedback approach.\n\nMethods: Participants will be assigned to parallel groups with balanced sex distribution. The study will compare responses to biofeedback versus a control intervention. Over a four-week period, each participant will undergo three treatment sessions:\n\nThe biofeedback group will be trained to control abdominothoracic musculature through cognitive intervention, supported by original visual materials, both before and after a standardized test meal.\n\nThe control group will receive a placebo capsule prior to the test meal, and regurgitation episodes will be recorded.\n\nFollowing the initial session, biofeedback participants will continue with daily exercises, while control participants will take a placebo with each meal. Treatment response will be assessed by comparing outcomes before and after the intervention. After post-treatment assessment, control group participants will be offered the opportunity to receive biofeedback therapy.\n\nRelevance: This project aims to determine the efficacy of a simplified mechanistic intervention for rumination. If successful, this approach could be adopted in additional healthcare settings.",[81],"Rumination Syndrome","2025-07-03",{"date":84,"type":85},"2025-07-09","ACTUAL",{"date":87,"type":85},"2025-05-02",{"date":89,"type":75},"2026-10",{"name":5,"class":6},1]