[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527428":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":80,"collaborators":26,"id":83,"slug":26,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":26,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":26,"overallStatus":63,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Micro-encapsulated tributyrin granules, 4 grams three times daily, for a maximum of 14 days",[13],"Dietary Supplement: Micro-encapsulated granules of tributyrin (intervention)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Micro-encapsulated sunflower oil granules, 4 grams three times daily, for a maximum of 14 days",[19],"Dietary Supplement: Micro-encapsulated granules of sunflower oil (placebo)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Micro-encapsulated granules of tributyrin (intervention)","Three times daily 4 grams of micro-encapsulated granules of tributyrin, for a maximum of 14 days",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Micro-encapsulated granules of sunflower oil (placebo)","Three times daily 4 grams of micro-encapsulated granules of sunflower oil, for a maximum of 14 days",[15],[32],{"name":33,"affiliation":5,"role":34},"H. C. van Santvoort, dr. prof.","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Hannah Pauw, MD","CONTACT","0883207051","+31","ha.pauw@antoniusziekenhuis.nl",[43,62],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Reinier de Graaf Gasthuis","NOT_YET_RECRUITING","Delft","South Holland","2625AD","Netherlands","NL",{"type":52,"coordinates":53},"Point",[54,55],4.35556,52.00667,{"lat":55,"lon":54},[58],{"name":59,"role":38,"phone":60,"phoneExt":40,"email":61},"Rutger Quispel, dr. MD.","0152603089","r.quispel@rdgg.nl",{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":49,"countryCode":50,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"RECRUITING","Nieuwegein","Utrecht","3435CM",{"type":52,"coordinates":68},[69,70],5.08056,52.02917,{"lat":70,"lon":69},[73,77],{"name":74,"role":38,"phone":75,"phoneExt":40,"email":76},"Hjalmar C. van Santvoort, Prof. dr.","0883201942","h.van.santvoort@antoniusziekenhuis.nl",{"name":78,"role":38,"phone":79,"phoneExt":40,"email":41},"Hannah Pauw, drs.","0623559868",{"type":34,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"HC van Santvoort","dr. prof.","100527428",false,"NCT06147635","Prophylactic Tributyrin Supplementation in Acute Pancreatitis","Prophylactic Tributyrin Supplementation in Acute Pancreatitis; a Phase IIa (Proof of Concept) Double-blind Randomized Placebo-controlled Food Supplement Trial","PARROT","Inclusion Criteria:\n\n* First episode of acute pancreatitis (AP)\n* Able to read and\u002For understand the study procedures\n* Able to give informed consent (or their legal representatives)\n* \\\u003C24 hours after diagnosis of AP\n* \\\u003C72 hours after onset of symptoms of AP\n\nExclusion Criteria:\n\n* Pancreatitis due to endoscopic retrograde cholangiopancreatography (ERCP), malignancy or trauma\n* Post-operative pancreatitis\n* Intra-operative diagnosis\n* Immunocompromised patients (history or current immunosuppressive treatment such as chemotherapy, radiotherapy, longer use of immunosuppressive medication or recent high doses, immunocompromised illness' such as AIDS, leukemia, lymphoma)\n* Pregnancy and\u002For lactation\n* Age \\\u003C18 years old\n* History of recurrent or chronic (MANNHEIM criteria25) pancreatitis (see Appendix 15.1 for definition)","ALL","18 Years",{"count":93,"type":94},92,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","The goal of this clinical trial is to investigate the possible effects of tributyrin supplementation in patients with a first episode of acute pancreatitis. The main question it aims to answer is:\n\n• The effect of oral tributyrin supplementation on the plasma endotoxin level\n\nParticipants will be randomized between two groups: intervention and control group. They will receive:\n\n\\- three times daily 4grams of micro-encapsulated granules of tributyrin, and the control group three times daily 4 grams of micro-encapsulated sunflower oil (i.e. placebo), for a total of 14 days\n\nIn total 92 adult patients with a first episode of acute pancreatitis will be included.",[100],"Acute Pancreatitis","2024-06-17",{"date":103,"type":104},"2024-06-20","ACTUAL",{"date":106,"type":104},"2024-02-12",{"date":108,"type":94},"2027-01",{"name":5,"class":6},2]