[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654647":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":36,"studyPopulation":28,"armGroups":37,"interventions":44,"overallOfficials":50,"centralContacts":55,"locations":65,"responsibleParty":83,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":28,"studyType":102,"phases":103,"briefSummary":104,"conditions":105,"keywords":118,"overallStatus":124,"whyStopped":28,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"metaX Institut fuer Diatetik GmbH","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Compliance","Compliance with the recommended intake of the usually prescribed protein substitute is assessed by the dietitian at baseline. Usage and compliance with the study product are recorded daily from day 1 to day 7 using a standardised form. Using the form, patients have to record the amount of the study product consumed in comparison to the prescribed doses. The reason for not consuming the full dose will be recorded by the patient\u002Fparent\u002Fcaregiver as free text. Patients are asked to state whether the study product is easy to prepare with yes or no.","daily; from day 1 to day 7",[14,17,20,24],{"measure":15,"description":16,"timeFrame":12},"Gastro-intestinal tolerance","Gastro-intestinal side effects (including diarrhoea, constipation, bloating or abdominal distension, nausea, vomiting, burping, flatulence or regurgitation and abdominal discomfort or pain) will be assessed at baseline and daily (from day 1 to day 7) via a standardised questionnaire using the following scale: none today, mild, moderate, or severe \u002F really troublsome.",{"measure":18,"description":19,"timeFrame":12},"Patient Acceptability","Accepatbility (ease of use, taste, texture, palatability) will be assessed daily during the study period and at the end of the study via a standardised questionnaire with a rating scale of 5 (great) to 1 (terrible).",{"measure":21,"description":22,"timeFrame":23},"Metabolic Control","Weekly routine finger prick blood spots will be collected and analysed for phenylalanine and tyrosine as is usual clinical practice.","baseline (day 1) and day 7",{"measure":25,"description":26,"timeFrame":27},"Incidence of study product emergent events","All adverse events will be recorded throughout the study (as and when they occur). There is no specific time frame as the frequency of adverse events can not be predicted. But as the study product is already commercially available occurance of any adverse event is unlikely.","throughout the study; from day 1 to day 7",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"NA","SINGLE_GROUP","open-label, observational","TREATMENT",{"masking":35,"maskingDescription":28,"whoMasked":28},"NONE","The principle treatment for children with Phenylketonuria (PKU) or Hyperphenylalaninemia (HPA) is a low protein diet. Part of this treatment requires the administration of a protein substitute in order to meet basic protein requirements for normal growth and development. Several brands of protein substitutes for PKU\u002FHPA are already available in various presentations. However, compliance with taking protein substitutes continues to be a challenge. As a low protein diet is usually recommended for life, long term compliance is always a major concern. As a result, improving the choice in terms of product type may aid compliance.\n\nXPhe Piccos is a slow release, phenylalanine-free protein substitute in a tiny tablet form, enriched with vitamins, minerals and trace elements and designed for children and adults with PKU\u002FHPA. XPhe Piccos is a food for special medical purposes (FSMP), as defined by the Delegated Regulation (EU) 2016\u002F128 of 25 September 2015 supplementing Regulation (EU) No 609\u002F2013 of 12 June 2013, used for the dietary management of PKU\u002FHPA.\n\nIt is anticipated that XPhe Piccos will be a suitable alternative option for patients with PKU\u002FHPA broadening the variety of protein substitutes they can choose from in order to suit their lifestyle and preferences.\n\nThis is a prospective, single-arm, open-label, observational tolerance study with 10 children with PKU. Subjects who are currently taking a second stage protein substitute will be recruited for a 7-day trial, taking the new ready-to-use slow release, phenylalanine-free protein substitute tablets to evaluate the tolerability and acceptability of the study product. Therefore, subjects will replace some or all of their usual protein substitute with the new product.\n\nDuring the 7-day trial subjects or caregivers will be asked to complete a daily questionnaire recording information on:\n\n* Usage and compliance\n* Ease of use and any issues with administration\n* Any gastro-intestinal side-effects.\n\nA questionnaire will also be completed at the beginning and end of the study that will consider perceptions about taste, appearance, smell, ease of administration of the usually used product and the study product; how it is taken; and any other problems or symptoms.\n\nThe amount of tablets prescribed will be calculated to provide the same amount of protein as their usual protein substitute.\n\nSubjects will continue to have weekly finger-prick blood spot tests as is routine in PKU. The results whilst on the study product will be compared with results whilst on their usual protein substitute.\n\n10 children with PKU will be recruited. When an appropriate subject has been identified, a study information sheet will be sent to the subject or parents\u002F caregivers. They will be invited to request further information about the study if they wish by contacting the Lead Dietitian.\n\nRecruitment of each patient will be by written informed consent, which will be completed by the parents\u002F primary caregivers and taken by the Lead Dietitian. Children will also complete an assent\u002Fconsent form and will receive an information sheet, if considered appropriate for their level of understanding.",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Participant group","EXPERIMENTAL","Subjects who are currently taking a second stage phenylalanine-free\u002Flow-Phe protein substitute will be recruited. Subjects will take the study product for 7 days. Subjects will replace some or their entire protein substitute with the study product. The appropriate amount of protein substitute will be calculated to provide the same amount of protein as their usual protein substitute. Intervention: Dietary Supplement: Slow release, phenylalanine-free protein substitute tablets.",[43],"Dietary Supplement: Slow release, phenylalanine-free protein substitute tablets",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":28},"DIETARY_SUPPLEMENT","Slow release, phenylalanine-free protein substitute tablets","The slow release, phenylalanine-free protein substitute in tablet form (XPhe Piccos) is a food for special medical purposes (FSMP) for use in the dietary management of Phenylketonuria or Hyperphenylalaninemia. The product is suitable from 3 years of age and over.\n\nXPhe Piccos are a highly concentrated phenylalanine-free protein supplement in the form of very small tablets\u002Fpellets enriched with vitamins, minerals and trace elements. XPhe Piccos are characterized by a prolonged release of the amino acids.",[39],[51],{"name":52,"affiliation":53,"role":54},"Anita MacDonald, Professor","Birmingham Women's and Children's NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":28,"email":60},"Bernhard Hoffmann, PhD","CONTACT","+49 6031 166 72 71","behoffmann@metax.org",{"name":62,"role":58,"phone":63,"phoneExt":28,"email":64},"Yvonne Muecke, PhD","+49 6031 166 72 79","yvonne.muecke@metax.org",[66],{"facility":67,"status":28,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Birmingham Children´s Hospital","Birmingham","England","B4 6NH","United Kingdom","UK",{"type":74,"coordinates":75},"Point",[76,77],-1.89983,52.48142,{"lat":77,"lon":76},[80],{"name":52,"role":58,"phone":81,"phoneExt":28,"email":82},"+44 1213338024","anita.macdonald@nhs.net",{"type":84,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[86],{"name":53,"class":87},"OTHER","100654647","acceptability-and-tolerance-market-research-of-a-slow-release-phenylalanine-free-protein-substitute-for-the-dietary-management-of-phenylketonuria-100654647",false,"NCT07802366","Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU","XPhe Piccos - Acceptability and Tolerance Market Research","XPhePiccosMR","Inclusion Criteria:\n\n* Diagnosis of PKU or HPA requiring a phenylalanine-free protein substitute.\n* Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days.\n* Subjects aged 3 years and above.\n* Written informed assent\u002Fconsent obtained from subject and\u002For parental caregiver, depending on subject age.\n\nExclusion Criteria:\n\n* Presence of serious concurrent illness.\n* Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.\n* Any subject having taken antibiotics over the previous 2 weeks leading up to the study.\n* Subjects less than 3 years of age","ALL","3 Years","18 Years",{"count":100,"type":101},10,"ESTIMATED","INTERVENTIONAL",[30],"XPhePiccosMR is a prospective, single-arm, open label, observational study that aims to evaluate the acceptability and tolerability of XPhe Piccos, a slow-release, phenylalanine-free protein substitute in the form of tiny tablets, for use in the dietary management of phenylketonuria (PKU) in children aged three years and older.",[106,107,108,109,110,111,112,113,114,115,116,117],"Phenylketonuria (PKU) and Hyperphenylalaninemia","Brain Diseases, Metabolic, Inborn","Brain Disorder, Metabolic","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Amino Acid Metabolism, Inborn Errors","Metabolism, Inborn Errors","Genetic Disease, Inborn","Genetic Diseases, Inborn","Metabolic Diseases","Nutritional and Metabolic Diseases",[119,120,121,122,123],"PKU","HPA","protein substitute","7-day trial","slow release","NOT_YET_RECRUITING","2026-10-06",{"date":127,"type":128},"2026-10-09","ACTUAL",{"date":130,"type":101},"2026-10-15",{"date":132,"type":101},"2027-08-01",{"name":5,"class":6},1]