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Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study
Sponsor: University of Glasgow
Summary
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. The 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.
Official title: 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
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-03-27
Completion Date
2030-08
Last Updated
2026-04-13
Healthy Volunteers
Yes
Conditions
Interventions
enteral nutrition
Dietary intervention: a liquid food replacement intervention involving replacing varying amounts of energy requirements with a nutritionally complete liquid formula.
Locations (6)
The Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom
University Hospital Crosshouse
Crosshouse, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Royal Hospital for Children & Young People
Edinburgh, United Kingdom
Royal Hospital For Children
Glasgow, United Kingdom
University Hospital Wishaw
Wishaw, United Kingdom