[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06369753":3,"trial-entities:NCT06369753":15,"trial-summary:NCT06369753":15},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":44,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":63,"locations":66,"central_contacts":146,"overall_officials":152,"references":156,"see_also_links":165},"NCT06369753","PR(AG)459\u002F2023B","Visible Abdominal Distension","Tratamiento de la distensión Abdominal Funcional","RECRUITING","2026-10","2025-10","2025-10-31","2025-07-30","Hospital Universitari Vall d'Hebron Research Institute","OTHER",null,"Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.\n\nAim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.\n\nSelection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.\n\nBiofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.\n\nPlacebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.",[18,19,20],"Irritable Bowel Syndrome","Dyspepsia","Functional Bloating",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},100,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Biofeedback","Three sessions of biofeedback intervention will be performed during the first 3 weeks of the intervention period. Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"Placebo","Three sessions of placebo intervention will be performed during the first 3 weeks of the intervention period. Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Visible abdominal distension","Distension score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention.","4 weeks",[45,48],{"measure":46,"description":47,"timeFrame":43},"Sensation of abdominal pressure\u002Ffullness","Sensation score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention.",{"measure":49,"description":50,"timeFrame":43},"Sensation of abdominal discomfort\u002Fpain","Sensation score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention","ALL","18 Years","80 Years",true,{"inclusion":56,"exclusion":58,"raw_text":62},[57],"episodes of visible abdominal distension triggered by meal ingestion",[59,60,61],"organic cause detected by clinical work-up","constipation","abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation","Inclusion Criteria:\n\n* episodes of visible abdominal distension triggered by meal ingestion\n\nExclusion Criteria:\n\n* organic cause detected by clinical work-up\n* constipation\n* abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation",[64,65],"ADULT","OLDER_ADULT",[67,82,96,105,113,130,138],{"facility":68,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"G. Oppenheimer Center for Neurobiology of Stress and Resilience","Los Angeles","California","90095","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Lin Chang, M.D.","CONTACT","(310) 206-0192","LinChang@mednet.ucla.edu",{"lat":80,"lon":81},34.05223,-118.24368,{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":93},"McMaster University","Hamilton","Ontario","ON L8S 4L8","Canada",[89],{"name":90,"role":76,"phone":91,"email":92},"Premysl Bercic, M.D.","(905) 525-9140","bercikp@mcmaster.ca",{"lat":94,"lon":95},43.25011,-79.84963,{"facility":97,"status":98,"city":99,"zip":100,"country":101,"geoPoint":102},"Bordeaux University Hospital","ACTIVE_NOT_RECRUITING","Bordeaux","33000","France",{"lat":103,"lon":104},44.84124,-0.58046,{"facility":106,"status":98,"city":107,"zip":108,"country":109,"geoPoint":110},"Santa Orsola Hospital","Bologna","40138","Italy",{"lat":111,"lon":112},44.49381,11.33875,{"facility":114,"status":115,"city":116,"zip":117,"country":118,"contacts":119,"geoPoint":127},"Hospital Universitari Vall d'Hebron","NOT_YET_RECRUITING","Barcelona","08035","Spain",[120,124],{"name":121,"role":76,"phone":122,"email":123},"Jordi Serra, M.D","34932746259","jordi.serrra@vallhebron.cat",{"name":125,"role":76,"email":126},"Fernando Azpiroz, MD","azpiroz.fernando@gmail.com",{"lat":128,"lon":129},41.38879,2.15899,{"facility":131,"status":98,"city":132,"zip":133,"country":134,"geoPoint":135},"Sahlgrenska Hospital, Gothenburg","Gothenburg","413 45","Sweden",{"lat":136,"lon":137},57.70716,11.96679,{"facility":139,"status":98,"city":140,"zip":141,"country":142,"geoPoint":143},"Manchester University","Manchester","M14 9PR","United Kingdom",{"lat":144,"lon":145},53.48095,-2.23743,[147,149],{"name":125,"role":76,"phone":148,"email":126},"34 932746259",{"name":150,"role":76,"phone":148,"email":151},"Jordi Serra, MD","jordi.serra@vallhebron.cat",[153],{"name":125,"affiliation":154,"role":155},"University Hospital Vall d'Hebron","PRINCIPAL_INVESTIGATOR",[157,161],{"pmid":158,"type":159,"citation":160},"38467383","BACKGROUND","Barba E, Livovsky DM, Accarino A, Azpiroz F. Thoracoabdominal Wall Motion-Guided Biofeedback Treatment of Abdominal Distention: A Randomized Placebo-Controlled Trial. Gastroenterology. 2024 Aug;167(3):538-546.e1. doi: 10.1053\u002Fj.gastro.2024.03.005. Epub 2024 Mar 11.",{"pmid":162,"type":163,"citation":164},"28705783","RESULT","Barba E, Accarino A, Azpiroz F. Correction of Abdominal Distention by Biofeedback-Guided Control of Abdominothoracic Muscular Activity in a Randomized, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1922-1929. doi: 10.1016\u002Fj.cgh.2017.06.052. Epub 2017 Jul 11.",[]]