[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626308":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":39,"locations":49,"responsibleParty":106,"collaborators":18,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":18,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":52,"whyStopped":18,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Lionhealth Srl Società Benefit","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL","Nutritional counseling + LH VIOLA oral supplementation. Patients receive ≥412 kcal\u002Fday of LH VIOLA for 16 weeks, in addition to standard nutritional counseling delivered by a clinical dietitian.",[13],"Dietary Supplement: LH VIOLA Supplementation",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Nutritional counseling alone. Patients receive standard nutritional counseling delivered by a clinical dietitian.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","LH VIOLA Supplementation","Oral administration of LH VIOLA, a specialized medical food (≥412 kcal\u002Fday), for 16 weeks, together with nutritional counseling provided by a clinical dietitian. Participants monitored for adherence, tolerability, weight, body composition, and muscle strength.",[9],[26,30,33,36],{"name":27,"affiliation":28,"role":29},"Antonio Di Sabatino, MD - PhD","S.C. General Medicine Fondazione IRCCS Policlinico San Matteo - Pavia","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Daniela Pugliese, MD - PhD","Emergenza e Medicina Interna - Ospedale Isola Tiberina-Gemelli Isola",{"name":34,"affiliation":35,"role":29},"Alessandro Armuzzi, MD - PhD","IBD Center at IRCCS Humatitas Research Hospital - Department of Biomedical Sciences",{"name":37,"affiliation":38,"role":29},"Fabiana Castiglione, MD - PhD","Department of Clinical Medicine and Surgery at AOU Federico II",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":18,"email":44},"Roberta Majer, Pharmaceutical Chemistry and T","CONTACT","+39 3357664333","studiclinici@lionhealth.tech",{"name":46,"role":42,"phone":47,"phoneExt":18,"email":48},"Lucio Vitiello, Biological Sciences","+39 3331756863","vitiello@lionhealth.tech",[50,68,80,93],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"IRCCS Humanitas","RECRUITING","Rozzano","Milano","20089","Italy","IT",{"type":59,"coordinates":60},"Point",[61,62],9.1559,45.38193,{"lat":62,"lon":61},[65],{"name":34,"role":42,"phone":66,"phoneExt":18,"email":67},"+390282248282","alessandro.armuzzi@hunimed.eu",{"facility":69,"status":52,"city":70,"state":18,"zip":18,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"AOU Federico II","Naples",{"type":59,"coordinates":72},[73,74],14.26811,40.85216,{"lat":74,"lon":73},[77],{"name":37,"role":42,"phone":78,"phoneExt":18,"email":79},"+39 081 7463849","fabcasti@unina.it",{"facility":81,"status":52,"city":82,"state":18,"zip":83,"country":56,"countryCode":57,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"IRCCS Policlinico San Matteo - Pavia","Pavia","27100",{"type":59,"coordinates":85},[86,87],9.15917,45.19205,{"lat":87,"lon":86},[90],{"name":27,"role":42,"phone":91,"phoneExt":18,"email":92},"+39 0382502973","a.disabatino@smatteo.pv.it",{"facility":94,"status":52,"city":95,"state":18,"zip":96,"country":56,"countryCode":57,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Ospedale Isola Tiberina - Gemelli Isola","Roma","00186",{"type":59,"coordinates":98},[99,100],11.10642,44.99364,{"lat":100,"lon":99},[103],{"name":31,"role":42,"phone":104,"phoneExt":18,"email":105},"+39 0668370502","daniela.pugliese@fbf-isola.it",{"type":107,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100626308","partial-enteral-nutrition-to-prevent-weight-loss-and-sarcopenia-in-ibd-patients-at-nutritional-risk---simba-100626308",false,"NCT07433946","Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA","Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA","SIMBA","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Crohn's Disease or Ulcerative Colitis\n* At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)\n* Ability to provide informed consent\n* Women of childbearing potential must use effective contraception\n\nExclusion Criteria:\n\n* Following an exclusion diet (CDED)\n* Current hospitalization\n* Pregnancy\n* Requirement for a low-protein diet","ALL","18 Years","65 Years",{"count":120,"type":121},146,"ESTIMATED","INTERVENTIONAL",[124],"NA","This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers.\n\nIBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk.\n\nParticipants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal\u002Fday) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA\u002FBIVA, vitamin B12\u002FD, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score).\n\nThe study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.",[127,128,129,130],"Ulcerative Colitis (Disorder)","Crohn Disease","Malnutrition or Risk of Malnutrition","IBD",[130,132,133,134,135,136,137],"Malnutrition","Sarcopenia","ONS","enteral nutrition","weight loss","clinical nutrition","2026-06-22",{"date":140,"type":141},"2026-06-25","ACTUAL",{"date":143,"type":141},"2026-03-09",{"date":145,"type":121},"2027-01-31",{"name":5,"class":6},4]