[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634389":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":36,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":84,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Center of New Medical Technologies","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Functional Dyspepsia",null,"Adults aged 18 years and older with functional dyspepsia diagnosed according to Rome IV criteria. Participants complete baseline and follow-up assessments of quality of life, psychoemotional status, and pain severity. Helicobacter pylori status is assessed in this cohort.",[13],"Diagnostic Test: Questionnaire and Symptom Assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"Irritable Bowel Syndrome","Adults aged 18 years and older with irritable bowel syndrome diagnosed according to Rome IV criteria. Participants complete baseline and follow-up assessments of quality of life, psychoemotional status, pain severity, and stool characteristics, including Bristol stool scale assessment.",[18],"Diagnostic Test: Helicobacter pylori Status Assessment",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Questionnaire and Symptom Assessment","Assessment includes SF-36, PHQ-9, GAD-7, PHQ-15, visual analogue scale for pain, and Bristol stool scale as applicable.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Helicobacter pylori Status Assessment","Helicobacter pylori status in participants with functional dyspepsia is assessed using available laboratory or diagnostic methods, including 13C urea breath test, stool PCR analysis, rapid urease test, or esophagogastroduodenoscopy with biopsy, as applicable.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Evgeniya V Shrainer, PhD","CONTACT","983 300 22 05","+7","shrayner_ev@cnmt.ru",[37],{"facility":5,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Novosibirsk","Novosibirsk Oblast","630090","Russia","RU",{"type":44,"coordinates":45},"Point",[46,47],82.93175,55.02259,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":34,"email":53},"Andrei V Ponomarenko, MD","9628316017","dayshadoff@gmail.com",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100634389","psychoemotional-status-and-functional-gastrointestinal-disorders-100634389",false,"NCT07539051","Psychoemotional Status and Functional Gastrointestinal Disorders","Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine","Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of irritable bowel syndrome and\u002For functional dyspepsia according to Rome IV criteria\n* Written informed consent for participation in the study\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Clinical presentation not meeting Rome IV criteria\n* Inflammatory bowel disease\n* Pregnancy or lactation\n* Malignant neoplasms of any localization\n* History of gastrointestinal surgery","ALL","18 Years",{"count":66,"type":67},150,"ESTIMATED","OBSERVATIONAL","This prospective cohort study will evaluate the influence of psychoemotional status on the clinical course and quality of life of adult patients with functional dyspepsia and\u002For irritable bowel syndrome diagnosed according to Rome IV criteria. The study aims to assess the contribution of affective and somatoform disorders to quality of life and symptom burden in these patients. In participants with functional dyspepsia, the association of Helicobacter pylori status with psychoemotional status and quality of life will also be evaluated. Patients will complete validated questionnaires assessing quality of life, depression, anxiety, and somatization at baseline and again during follow-up after treatment. Clinical symptoms, pain severity, stool characteristics, and H. pylori status will also be assessed as applicable.",[9,15],[72,73,74,75,76,77,78,79,80,81,82,83],"Psychoemotional Status","Quality of Life","Anxiety","Depression","Somatization","PHQ-9","GAD-7","PHQ-15","SF-36","Helicobacter pylori","Rome IV","Gut-Brain Interaction","NOT_YET_RECRUITING","2026-04-13",{"date":87,"type":88},"2026-04-20","ACTUAL",{"date":90,"type":67},"2026-05-01",{"date":92,"type":67},"2028-05-01",{"name":5,"class":6},1]