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RECRUITING
NCT07522528
NA

Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study

Sponsor: University of Glasgow

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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