Hypothesis summary
Two important treatments currently used to manage CD are a liquid-only diet (known as Exclusive Enteral Nutrition (EEN)) where specialised milkshakes replace the entire diet for up to 8 weeks (a first-line treatment for children), and special drugs (biologics). However, gut inflammation often returns when the unrestricted diet is recommenced and studies in adults show, even with intensive usage of biologics, disease remission rates can be lower than 55-60%. Evidence suggests liquid diets (that replace ≥50% of the unrestricted diet) alongside biologic therapy may improve responses to biologic drugs. However, research exploring the efficacy of this strategy in children with CD is lacking.
Our group has recently been studying whether replacing part of the normal diet with the specialised milkshakes, known as Partial Enteral Nutrition (PEN), will improve response to standard treatment with biologics in adults with active Crohn’s disease in the BIOPIC study. Following on from this, the BIOPIC-Kids study will investigate whether replacing diet with specialised milkshakes will improve response to standard treatment with biologics in children with CD.
To achieve this, children and young adults (6-18 years) with active CD who are commencing biologics as their standard of care will be randomised to either follow their unrestricted diet or replace their unrestricted diet with specialised milkshakes for 6 weeks.
Additionally, we will recruit participants receiving a liquid-only diet or starting biologic drugs alongside a liquid-only diet as their standard of care, to compare the outcomes of different treatments.
During the study, we will collect blood, urine, saliva and stool samples and information about the patients’ diet. These samples will be used to measure the participants’ responses to biologic therapy and enable us to detect changes in disease markers and the gut and oral microbiome. All CD participants will be followed up for up to 1-year from starting their induction treatment to see if the liquid diet combined with biologic therapy has any effect on the maintenance of remission.
Healthy volunteers will also be recruited to act as a comparison group for the CD participants, so we can study the differences in dietary habits, gut bacteria and oral