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

What this Trial Is About

Crohn's disease (CD) is a long-lasting condition causing inflammation in the gut. This research aims to find out if replacing a normal diet with specialized milkshakes for 6 weeks can help improve treatment response and maintain remission in children and young adults with active CD receiving biologic therapies. The study focuses on patients aged 6 to 18 years who are starting biologic treatment with TNF alpha inhibitors, aiming to compare diet approaches alongside these medications to better manage CD symptoms and disease activity. Participants will be randomly assigned or choose to follow either their usual unrestricted diet or replace varying amounts of their diet with a liquid formula called enteral nutrition for 6 weeks while receiving biologic treatments such as infliximab or adalimumab. Additional groups receiving exclusive enteral nutrition alone or combined with biologics will also be observed to compare different treatment outcomes. The study uses a proprietary liquid formula to replace energy intake and tracks effects during biologic induction therapy. Throughout the study, participants will be monitored for improvements in symptoms and disease markers over 10 to 12 weeks, with follow-up up to a year to assess sustained remission. Researchers will evaluate nutritional status, body composition, quality of life, immune markers, and gut and oral microbiome changes. Safety and treatment adherence will also be tracked, with various blood tests, questionnaires, and physical assessments included. Overall, the study spans over a year to assess both immediate and long-term treatment effects in pediatric CD patients.

Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study