[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malabsorption\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malabsorption":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100583561","elemental-028-extra-case-studies-100583561",false,"NCT06877923","Elemental 028 Extra Case Studies","Evaluating the Tolerance, Compliance and Acceptability of a Nutritionally Complete Amino Acid-based Nutritional Supplement for the Dietary Management of Conditions With a Severe Impairment of the Gastrointestinal Tract in Children and Adults: a Case Study Series","E028E","Inclusion Criteria:\n\n* Male or female\n* Over 3 years of age\n* Requiring an elemental feed (at least 30% of total energy requirements)\n* Written or electronic informed consent from patient, and\u002For from parent\u002Fcaregiver if applicable\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Requiring parenteral nutrition\n* Major hepatic or renal dysfunction\n* Participation in other studies within 1 month prior to entry of this study\n* Investigator concern around willingness\u002Fability of patient or parent\u002Fcaregiver to comply with protocol requirements","ALL","3 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content micronutrient profile has been developed to better meet the nutritional requirements of patients.\n\nThis series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.",[27,28,29,30,31,32],"Gastrointestinal Disease","Inflammatory Bowel Disease (IBD)","Short Bowel","Malabsorption","Allergies","Neurodegenerative Disorders","RECRUITING","2026-02-13",{"date":36,"type":37},"2026-02-17","ACTUAL",{"date":39,"type":37},"2025-05-01",{"date":41,"type":21},"2027-02",{"name":43,"class":44},"Nutricia UK Ltd","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100326501","a-90-day-phase-3open-labeled-exploratory-study-of-relizorb-100326501","NCT03530852","A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB","A 90 Day, Phase 3, Open Labeled Exploratory Study of RELiZORB to Evaluate Safety, Tolerability, and Nutrient Absorption in Children With Short Bowel Syndrome Who Are Dependent on Parenteral Nutrition","Inclusion Criteria:\n\n1. Male or female patients, ages 2 years to 18 years, inclusive.\n2. Diagnosed with SBS, as determined by medical history and PN dependence (i.e. need for PN for \\>60 days after intestinal resection or a bowel length \\\u003C25% of expected).\n3. Congenital or acquired gastrointestinal disease requiring surgical intervention that has occurred at least 3 months prior to screening.\n4. Patient is on parenteral lipid and at least 30% of daily caloric and fluid intake has been provided by PN for a least 6 months prior to screening\n5. Stable PN nutrition requirement, determined by less than 5% reduction in PN nutrition calories for at least 1 month prior to screening, or at the discretion of the investigator.\n6. Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator.\n7. Subject has an existing feeding tube, is receiving enteral nutrition via a pump at a rate\\>10ml\u002Fhr but \\\u003C120ml\u002Fhr, and is able to tolerate at least 10 ml\u002Fkg\u002Fday enteral nutrition.\n8. Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening.\n9. The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).\n10. The patient (if assent is applicable) or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the patient to all clinic visits and complete all study related procedures (as determined by the investigator).\n\nA parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information.\n\nExclusion criteria:\n\n1. Other causes of chronic liver disease other than SBS (i.e., hepatitis C, cystic fibrosis, biliary atresia, alpha 1 anti-trypsin deficiency, and Alagille syndrome).\n2. The patient has had a bowel lengthening procedure, including but not limited to, a STEP procedure.\n3. Any serum triglyceride concentration \\>400 mg\u002FdL at screening.\n4. Pancreatic insufficiency as defined as the use of pancreatic enzymes within 30 days prior to screening.\n5. Evidence of untreated intestinal obstruction or active stenosis, as determined by the investigator.\n6. Unstable absorption due to cystic fibrosis or known DNA abnormalities (i.e., familial adenomatous polyposis, Fanconi syndrome) as determined by the investigator.\n7. History of microvillus inclusion disease, as determined by medical history.\n8. Severe known dysmotility syndrome (i.e., pseudo-obstruction, gastroschisis-related motility disorders), as determined by the investigator.\n9. Initiation of teduglutide or other GLP-2 analogues within 6 months of screening\n10. Use of growth hormone, or supplemental glutamine within 3 months prior to screening.\n11. Use of cisapride within 30 days prior to screening.\n12. Active clinically significant pancreatic or biliary disease, as determined by the investigator.\n13. Patients are receiving formulas that are not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas)\n14. Determined by the investigator to be unsuitable for participation for any reason.","2 Years","18 Years",{"count":56,"type":21},32,[24],"Children with inadequate intestinal absorption due to loss of large amounts of small bowel require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to complications including liver failure. Tube feeding directly to the small intestine avoids the complications of IV nutrition, but fats are not fully digestible due to inadequate bowel function. We propose to predigest the fat using a small cartridge attached to the feeding tube to allow for rapid absorption with the possibility of reducing or eliminating the need for intravenous nutrition",[60,30],"Short Bowel Syndrome","2025-12-15",{"date":63,"type":37},"2025-12-17",{"date":65,"type":37},"2018-11-21",{"date":67,"type":21},"2028-09-30",{"name":69,"class":70},"Boston Children's Hospital","OTHER"]