Biologics and Paediatric Enteral Nutrition in Crohn’s Disease Study
Research type
Research Study
Full 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.
IRAS ID
353897
Contact name
Konstantinos Gerasimidis
Contact email
Sponsor organisation
University of Glasgow
Duration of Study in the UK
5 years, 0 months, 0 days
Research 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.
In this study, we want to investigate whether replacing the normal diet with specialised milkshakes for 6 weeks improves response to treatment 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 100%, 80% and then 65% 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 be recruited to compare different treatment outcomes.
We will compare the proportion of participants whose symptoms and disease markers, in collected blood and faeces samples, improve after 6 and 10-12 weeks and explore any effects on nutritional status and quality of life. Additionally, we will investigate if gut and oral microbe changes are associated with participants' eating habits and responses to biologics. Participants will be followed up for up to 1-year from starting their treatment to study effects on the maintenance of CD remission. Healthy volunteers will also be recruited to act as a comparison group for the CD patients.REC name
West of Scotland REC 4
REC reference
25/WS/0105
Date of REC Opinion
20 Aug 2025
REC opinion
Further Information Favourable Opinion