[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594704":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":43,"locations":10,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":64,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":10},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"patients with SSc and PPI-refractory GERD symptoms",null,"Study Subjects:\n\nPatients will be recruited from the outpatient clinics of the Autoimmune Diseases Unit or the Gastroenterology Department at the Vall d'Hebron University Hospital (HUVH), Barcelona.\n\nInclusion Criteria:\n\nDiagnosis of systemic sclerosis according to the 2013 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria and\u002For LeRoy criteria.\n\nAge ≥ 18 years.\n\nPresence of gastroesophageal reflux symptoms, defined as heartburn and\u002For regurgitation occurring at least three times per week over the past three months, despite ongoing treatment with PPIs.",[13,14,15],"Other: educational healthcare intervention","Diagnostic Test: Objective assessment of GI motility","Diagnostic Test: Evaluation of GERD severity",[17,26,36],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"educational healthcare intervention","This intervention will be applyed at the beginning of the study",[9],[22,23,24,25],"avoiding late dinners","not lying down for at least 2 hours after meals","avoiding tobacco and alcohol","avoiding large or high-fat meals",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIAGNOSTIC_TEST","Objective assessment of GI motility","Objetive assessment of gastrointestinal dysmotility in GI organs (esophagus, stomach, small bowel) will be performed using state of the art tests.",[9],[32,33,34,35],"Gastric emptying test","Small bowel manometry","High-resolution esophageal manometry","Abdominal CT scan",{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Evaluation of GERD severity","Objective evaluation of GERD severity on PPI therapy will be performed.",[9],[41,42],"upper GI endoscopy (on PPI)","pH-impedance monitoring (on PPI)",[44],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Luis G Alcala-Gonzalez, MD PhD","CONTACT","934893000","2896","luisgerardo.alcala@vallhebron.cat",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100594704","ppi-refractory---gerd-mechanisms-in-systemic-sclerosis-100594704",false,"NCT07022912","PPI Refractory - GERD Mechanisms in Systemic Sclerosis","Objective Assessment of Gastrointestinal Involvement in Patients With Systemic Sclerosis and Gastroesophageal Reflux Symptoms Refractory to Proton Pump Inhibitors.","Inclusion Criteria:\n\n* Systemic sclerosis by ACR\u002FEULAR 2023 criteria AND\u002FOR Leroy Medsger classification criteria\n* Reflux symptoms (Heartburn AND\u002FOR Regurgitation), at least 3 times a week over the last 3 months despite PPI therapy\n\nExclusion Criteria:\n\n* Previous surgery altering the anatomy or motility of the upper digestive tract, including fundoplication, esophageal myotomy, gastrectomy, or bariatric surgery.\n\nSevere pulmonary or cardiac disease requiring intravenous vasodilators, continuous oxygen therapy, or ventricular assist devices, preventing the performance of gastrointestinal motility tests.\n\nPregnancy at the time of evaluation or planned pregnancy during the duration of the study.\n\nNeuromuscular disorders other than systemic sclerosis that may affect gastrointestinal motility.\n\nPrior diagnosis of functional gastrointestinal disorders, such as irritable bowel syndrome or functional dyspepsia, that may interfere with the interpretation of results.","ALL","16 Years",{"count":62,"type":63},147,"ESTIMATED","5 Months","OBSERVATIONAL","The goal of this observational study is to learn about the mechanisms of gastroesophageal reflux disease (GERD) in patients with systemic sclerosis (SSc) who continue to experience reflux symptoms despite treatment with proton pump inhibitors (PPIs). The main question it aims to answer is:\n\nWhat are the underlying gastrointestinal mechanisms contributing to PPI-refractory reflux symptoms in patients with SSc?\n\nParticipants with a confirmed diagnosis of SSc and persistent reflux symptoms despite PPI therapy will undergo standard-of-care diagnostic tests, including high-resolution esophageal manometry and pH-impedance monitoring. Clinical data and test results will be collected and analyzed to identify patterns of motility dysfunction and reflux characteristics associated with refractory symptoms.",[68,69],"Systemic Sclerosis (SSc)","GERD (Gastroesophageal Reflux Disease)",[71,72,73],"GERD mechanisms","gastrointestinal involvement","systemic sclerosis","NOT_YET_RECRUITING","2025-06-06",{"date":77,"type":78},"2025-06-15","ACTUAL",{"date":80,"type":63},"2025-07-01",{"date":82,"type":63},"2027-07-01",{"name":5,"class":6}]