[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nutricia UK Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":137},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,65,88,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644644","pku-microtablets-case-studies-100644644",false,"NCT07671859","PKU Microtablets Case Studies","Evaluating the Adherence, Tolerance, Acceptability and Safety of a New Amino Acid Based, Microtablet Protein Substitute in PKU: a Case Study Series","Inclusion Criteria:\n\n* Male or female\n* Over 4 years of age\n* Patients diagnosed with any phenotype of PKU characterised by hyperphenylalaninaemia\n* Have been compliant in taking at least one protein substitute, providing at least 20g protein equivalent, for at least 1 month prior to trial commencement\n* Have a prescribed daily phenylalanine allowance for PKU\n* Written or electronic informed consent from patient, and\u002For from parent\u002Fcaregiver if applicable\n* Participants who are anticipated to be able to take at least 20g protein equivalent of the case study product per day\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* Allergy to any of the study product ingredients\n* Investigator concern around willingness\u002Fability of patient or parent\u002Fcaregiver to comply with protocol requirement\n* Treatment with Sapropterin dihydrochloride for less than 6 months","ALL","4 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","Phenylalanine (Phe) free protein substitutes are typically presented in ready to drink liquid or powder format and are made up with water to a set volume. Despite recent advancements related to the taste, scent and texture of commercially available protein substitutes, a proportion of PKU patients choose to consume tablet-based protein substitutes. Protein substitutes in tablet format may help overcome taste, scent and texture concerns associated with powdered and liquid preparations. Indeed, previous research has shown that protein substitute tablets are an effective strategy to manage PKU in children, teenagers and adults. Nonetheless, the daily burden and discipline required often impedes compliance, especially alongside the restrictive low-protein diet. Achieving compliance with multivitamin supplements when given alongside protein substitutes therefore becomes especially challenging. This is particularly true for adolescent, adult and maternal populations.\n\nPKU Microtablets have recently been developed. PKU Microtablets are a new phenylalanine-free tablet protein substitute combined with vitamins, minerals and trace elements. As patient acceptability is fundamental to the successful use of any protein substitute, investigation is needed to assess the compliance, tolerance and acceptability of PKU Microtablets as part of a low phenylalanine dietary regimen in PKU patients.\n\nThis series of case-studies aims to evaluate the gastrointestinal tolerance, acceptability, compliance, and safety of this protein substitute in both adults and children from 4 years. These case studies 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 specialist metabolic centres in the UK.",[26],"Phenylketonuria (PKU)","NOT_YET_RECRUITING","2026-06-23",{"date":30,"type":31},"2026-06-26","ACTUAL",{"date":33,"type":20},"2026-07-01",{"date":35,"type":20},"2027-07-01",{"name":37,"class":38},"Nutricia UK Ltd","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100538259","hydrolysed-rice-formula-study-100538259","NCT06288503","Hydrolysed Rice Formula Study","A Double-blind, Randomised-controlled Trial Evaluating a Hydrolysed Rice Formula Compared to a Cow's Milk Protein-based Extensively Hydrolysed Formula in Infants With Cow's Milk Allergy","Inclusion Criteria:\n\n* Male or female\n* Aged 0-13 months\n* Presenting to primary or secondary care with symptoms\u002Fclinical history suggestive of CMA\n* Will receive at least 30% of energy requirements from the study formula\n* Written informed consent from parent\u002Fcarer\n\nExclusion Criteria:\n\n* Severe CMA (including anaphylaxis) and\u002For requiring an AAF\n* Faltering growth (based on NICE guidelines36 - Appendix 1)\n* Previous allergy to any study product ingredients (including whey hydrolysate and\u002For rice)\n* Primary lactose intolerance\n* Food Protein-Induced Enterocolitis Syndrome (FPIES)\n* Exclusively breast fed\n* Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes\n* Severe hepatic or renal insufficiency\n* Premature infants (born \\\u003C37 weeks) with a corrected age of \\\u003C4 weeks\n* Requirement for any parenteral nutrition\n* Participation in other clinical intervention studies within 1 month of recruitment\n* Concern around the willingness\u002Fability of the caregiver to comply with the study protocol and\u002For study requirements","0 Months","13 Months",{"count":50,"type":20},86,[23],"This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms\u002Fclinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.",[54],"Cow's Milk Protein Allergy","RECRUITING","2026-04-09",{"date":58,"type":31},"2026-04-13",{"date":60,"type":31},"2024-02-01",{"date":62,"type":20},"2027-07",{"name":37,"class":38},2,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":39},"100625461","plant-protein-dominant-tube-feed-study-100625461","NCT07422935","Plant-Protein Dominant Tube Feed Study","Exploratory Randomised, Controlled Trial To Evaluate The Impact Of Four Nutritionally Complete, Plant-Protein Dominant, Enteral Tube Feeds On Long Term Outcomes In Community-Based Adults","Inclusion Criteria:\n\n* Male or female\n\n  -≥16 years of age\n* Using or requiring an enteral tube feed in the community as part of nutritional management plan\n* Expected to receive at least 500ml (≥500kcal) per day from one of the study products\n\nExclusion Criteria:\n\n* Receiving parenteral nutrition\n* Patients with major hepatic dysfunction (i.e., decompensated liver disease)\n* Patients with major renal dysfunction (i.e., requiring filtration or stage 4\u002F5 chronic kidney disease (CKD))\n* Patients receiving inpatient care\n* Known pregnancy or lactation\n* Participation in other clinical intervention studies within 1 month of this study\n* Allergy to any study product ingredients\n* Investigator concern regarding ability or willingness of patient to comply with the study requirements.","16 Years",{"count":74,"type":20},110,[23],"This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function",[78,79],"Enteral Nutrition (Food for Special Medical Purposes)","Enteral Feeds","2026-02-13",{"date":82,"type":31},"2026-02-20",{"date":84,"type":31},"2026-01-01",{"date":86,"type":20},"2027-03",{"name":37,"class":38},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":39},"100583561","elemental-028-extra-case-studies-100583561","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","3 Years",{"count":98,"type":20},30,[23],"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.",[102,103,104,105,106,107],"Gastrointestinal Disease","Inflammatory Bowel Disease (IBD)","Short Bowel","Malabsorption","Allergies","Neurodegenerative Disorders",{"date":109,"type":31},"2026-02-17",{"date":111,"type":31},"2025-05-01",{"date":113,"type":20},"2027-02",{"name":37,"class":38},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":39},"100588448","gmp-powdered-substitutes-in-pku-and-tyr-100588448","NCT06941532","GMP Powdered Substitutes in PKU and TYR","Evaluating the Adherence, Tolerance, Acceptability and Safety of New GMP-based Powdered Protein Substitutes in PKU and TYR: a Case Study Series","Inclusion Criteria:\n\n* Male or female\n* Over 3 years of age\n* Patients diagnosed with any phenotype of PKU characterised by hyperphenylalaninaemia or patients diagnosed with tyrosinaemia\n* Have been compliant in taking at least one protein substitute, providing at least 15g protein equivalents, for at least 1 month prior to trial commencement\n* Have a prescribed daily phenylalanine or phenylalanine and tyrosine allowance for PKU or TYR respectively\n* Written or electronic informed consent from patient, and\u002For from parent\u002Fcaregiver if applicable\n* Participants who are anticipated to be able to take at least one sachet of GMP Product per day\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* Allergy to any of the study product ingredients\n* Investigator concern around willingness\u002Fability of patient or parent\u002Fcaregiver to comply with protocol requirement",{"count":123,"type":20},40,[23],"Four new GMP-based protein substitutes have been developed to support the dietary management of PKU and TYR. These products are powdered protein substitutes, low in phenylalanine and low in phenylalanine and tyrosine respectively, with a mix of glycomacropeptide (GMP), essential and non-essential amino acids, carbohydrates, fibres, fats (including DHA) and micronutrients. The proteins in these new protein substitutes are based on GMP, a peptide isolated from milk during cheese manufacturing and the only known naturally derived protein source low in phenylalanine and tyrosine. The GMP is supplemented with other amino acids which are naturally low or not present in GMP, as well as carbohydrates, fats, fibre and micronutrients. Studies to date have illustrated that PKU patients who replace their regular phenylalanine-free amino acid-based formula with GMP-based foods may have better diet compliance and prefer the taste whilst maintaining metabolic control.\n\nThis series of case-studies aims to evaluate the gastrointestinal tolerance, acceptability, compliance, and safety of these four GMP based protein substitutes in both adults and children over 3 years. These case studies 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 specialist metabolic centres in the UK. A series of case studies is undertaken due to the rarity of these conditions, the diversity of patient types and the difficulty in recruiting these patients to trials.",[127,128],"Phenylketonuria","Tyrosinemia","2025-12-18",{"date":131,"type":31},"2025-12-19",{"date":133,"type":31},"2025-05-20",{"date":135,"type":20},"2026-12-31",{"name":37,"class":38},""]