[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633118":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":18,"centralContacts":31,"locations":41,"responsibleParty":125,"collaborators":129,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":18,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":87,"whyStopped":18,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"University of Glasgow","OTHER",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Enteral Nutrition","EXPERIMENTAL","Paediatric patients allocated to the enteral nutrition study arm will be asked to replace varying amounts of their daily energy requirements with a proprietary formula (Ready-To-Drink Modulen, Nestle, or Modulen IBD, Nestle) for 6 weeks alongside standard of care treatment with infliximab or adalimumab as induction therapy.",[13],"Dietary Supplement: enteral nutrition",{"label":15,"type":16,"description":17,"interventionNames":18},"Unrestricted Diet","NO_INTERVENTION","Paediatric patients allocated to the unrestricted diet study arm will be asked to follow their habitual, unrestricted diet for 6 weeks alongside standard of care treatment with infliximab or adalimumab as induction therapy.",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Exclusive Enteral Nutrition","An observational cohort of paediatric patients receiving standard of care treatment with exclusive enteral nutrition as induction therapy.",{"label":23,"type":16,"description":24,"interventionNames":18},"Exclusive enteral nutrition alongside Infliximab or Adalimumab Induction Therapy","An observational cohort of paediatric patients receiving standard of care treatment with exclusive enteral nutrition alongside infliximab or adalimumab as induction therapy.",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":18},"DIETARY_SUPPLEMENT","enteral nutrition","Dietary intervention: a liquid food replacement intervention involving replacing varying amounts of energy requirements with a nutritionally complete liquid formula.",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Konstantinos Gerasimidis, Professor","CONTACT","+441419560580","Konstantinos.Gerasimidis@glasgow.ac.uk",{"name":38,"role":34,"phone":39,"phoneExt":18,"email":40},"Sophie F Morris, BSc (Hons)","+447887804802","s.morris.2@research.gla.ac.uk",[42,59,72,85,99,112],{"facility":43,"status":44,"city":45,"state":18,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Royal Aberdeen Children's Hospital","NOT_YET_RECRUITING","Aberdeen","AB25 2ZG","United Kingdom","UK",{"type":50,"coordinates":51},"Point",[52,53],-2.09814,57.14369,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":18,"phoneExt":18,"email":58},"Iain S Chalmers, MBChB","iain.chalmers@nhs.scot",{"facility":60,"status":44,"city":61,"state":18,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"University Hospital Crosshouse","Crosshouse","KA2 0BE",{"type":50,"coordinates":64},[65,66],-4.55091,55.61258,{"lat":66,"lon":65},[69],{"name":70,"role":34,"phone":18,"phoneExt":18,"email":71},"Lawrence Armstrong, MBCHB, MRCPCH","Lawrence.Armstrong@aapct.scot.nhs.uk",{"facility":73,"status":44,"city":74,"state":18,"zip":75,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Ninewells Hospital","Dundee","DD1 9SY",{"type":50,"coordinates":77},[78,79],-2.97489,56.46913,{"lat":79,"lon":78},[82],{"name":83,"role":34,"phone":18,"phoneExt":18,"email":84},"Richard Hansen, MBChB, PhD, FRCPCH, FRCP Edin","richard.hansen2@nhs.scot",{"facility":86,"status":87,"city":88,"state":18,"zip":89,"country":47,"countryCode":48,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Royal Hospital for Children & Young People","RECRUITING","Edinburgh","EH16 4TJ",{"type":50,"coordinates":91},[92,93],-3.19648,55.95206,{"lat":93,"lon":92},[96],{"name":97,"role":34,"phone":18,"phoneExt":18,"email":98},"Richard K Russell, MBChB, MRCP, MRCPCH, PhD","Richard.Russell@nhs.scot",{"facility":100,"status":87,"city":101,"state":18,"zip":102,"country":47,"countryCode":48,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Royal Hospital For Children","Glasgow","G51 4TF",{"type":50,"coordinates":104},[105,106],-4.25763,55.86515,{"lat":106,"lon":105},[109],{"name":110,"role":34,"phone":18,"phoneExt":18,"email":111},"Lisa Gervais, MSc","Lisa.Gervais2@nhs.scot",{"facility":113,"status":44,"city":114,"state":18,"zip":115,"country":47,"countryCode":48,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"University Hospital Wishaw","Wishaw","ML2 0DP",{"type":50,"coordinates":117},[118,119],-3.91667,55.76667,{"lat":119,"lon":118},[122],{"name":123,"role":34,"phone":18,"phoneExt":18,"email":124},"Thomas J Jordan, MBBS, BSc","Thomas.Jordan@lanarkshire.scot.nhs.uk",{"type":126,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr Konstantinos Gerasimidis","Professor of Clinical Nutrition",[130,132,135,137,139,141],{"name":131,"class":6},"NHS Greater Clyde and Glasgow",{"name":133,"class":134},"NHS Lothian","OTHER_GOV",{"name":136,"class":134},"NHS Tayside",{"name":138,"class":134},"NHS Grampian",{"name":140,"class":6},"NHS Ayrshire and Arran",{"name":142,"class":134},"NHS Lanarkshire","100633118","biologics-and-paediatric-enteral-nutrition-in-crohns-disease-study-100633118",false,"NCT07522528","Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study","Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study (BIOPIC-Kids): Combining Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Children With Active Crohn's Disease","BIOPIC-Kids","Inclusion Criteria:\n\n* Eligible participants to the RCT are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \\>250 mg\u002Fkg and who have a clinical indication to initiate standard of care induction treatment with TNFα inhibitors (infliximab or adalimumab).\n* Eligible participants to the observational cohorts are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \\>250 mg\u002Fkg and who are due to initiate standard of care induction treatment with EEN therapy alongside TNFα inhibitors (infliximab or adalimumab) or standard of care induction treatment with EEN therapy without TNFα inhibitors (infliximab or adalimumab)\n\nExclusion Criteria:\n\n* Inability to provide consent to participate in the study (i.e., this applies to young adults (aged 16-18 years) who are old enough but unable to provide consent and carers (of children aged 6-15 years old) who are unable to provide consent on behalf of their child).\n* Presence of stoma or of short bowel syndrome.\n* Patients currently receiving oral or intravenous steroids at a dosage \\>20mg\u002Fday prednisolone or \\>9mg\u002Fday budesonide.\n* Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks.\n* CD with a major fistulising or symptomatic fibrotic stricturing phenotype.\n* Patients with comorbid anorexia nervosa.\n* Any clinical contraindication to use of exclusive enteral nutrition or partial enteral nutrition.\n* Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C.\n* Patients with untreated tuberculosis (latent or active).\n* Current enrolment in other studies of an investigational product or dietary intervention.\n* Food allergies, which do not permit participation in the study (e.g., cow's milk allergy).\n* Pregnant and\u002For breastfeeding individuals.",true,"ALL","6 Years","18 Years",{"count":156,"type":157},90,"ESTIMATED","INTERVENTIONAL",[160],"NA","Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation. Two important treatments currently used to manage CD are special drug injections (biologics) or a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 55-60%. The liquid-only diet also has a better safety and effectiveness profile than traditional treatments like steroids. However, gut inflammation often returns not long after the normal diet is re-introduced, and it is difficult for patients to stick to as their sole source of nutrition for 6-8 weeks.\n\nThe BIOPIC-Kids study aims to investigate whether replacing the normal diet with specialised milkshakes for 6 weeks improves response to treatment and maintenance of remission with biologics in children and young adults with CD. To achieve this, children and young adults (aged 6-18 years) with active CD commencing biologics as standard of care treatment will be randomly allocated to follow their normal diet OR replace varying amounts of their normal diet with specialised milkshakes for 6 weeks. Participants not wanting to be randomised can choose the group of their preference. Patients starting a liquid-only diet OR biologics alongside a liquid-only diet as standard of care treatment will also be recruited to compare different treatment outcomes.",[163],"Crohn's Disease (CD)",[165,166,20,167,168,169,170,171],"Crohn's Disease","Partial Enteral Nutrition","Biologic Therapy","Infliximab","Adalimumab","Combination Therapy","Paediatric","2026-04-03",{"date":174,"type":175},"2026-04-13","ACTUAL",{"date":177,"type":175},"2026-03-27",{"date":179,"type":157},"2030-08",{"name":5,"class":6},6]