At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- enteral nutrition (supplement)
- How long the study runs
- Study runs about 53 months (dates as stated)
- About the drug or intervention
- enteral nutrition — supplement: Dietary intervention: a liquid food replacement intervention involving replacing varying amounts of energy requirements with a nutritionally complete liquid formula.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 6 Years to 18 Years
- Who
- All
- Number of participants
- 90
- Started
- 2026-03-27
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease (cd)
- • NA - 90 participants
- • Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation
Who can take part?
- • Ages 6 Years to 18 Years
- • Diagnosed with crohn's disease (cd)
Where?
- • Aberdeen - The Royal Aberdeen Children's Hospital
- • Crosshouse - University Hospital Crosshouse
- • Dundee - Ninewells Hospital
- • Edinburgh - Royal Hospital for Children & Young People
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
90 Paediatric patients with active Crohn's disease (CD) who are due to start standard of care treatment with TNF alpha (TNFα) inhibitors infliximab(IFX) or adalimumab(ADA) will be recruited from six centres across Scotland for this study. Participants will be randomised, or allocated by their choice, to either follow their unrestricted diet or a liquid diet (enteral nutrition) that replaces varying amounts of their unrestricted diet for the first 6 weeks of IFX/ADA induction therapy. Observational cohorts receiving standard of care treatment with exclusive enteral nutrition (EEN therapy) or IFX/ADA alongside adjuvant EEN therapy will be recruited to compare the outcomes of different treatments. The investigators will compare the proportion of patients whose symptoms and disease markers will improve between the groups following 10-12 weeks of induction therapy, and how many of them will remain symptoms-free for up to a year following treatment. The study will also explore whether the study's liquid diet will influence patient's nutrition, body composition and quality of life. Additionally, host immunophenotype, inflammatory cytokines and the gut and oral microbiome, including composition and function will be explored. The primary aim of this study is to investigate if replacement of the habitual diet with varying amounts of enteral nutrition for 6 weeks in total, will improve rates of clinical remission and normalisation of biomarkers of mucosal healing in children and young adults with active CD receiving biologic therapy with TNFα inhibitors compared to children with active CD receiving biologic therapy and consuming their habitual, unrestricted diet. The secondary aim of this study is to investigate if the nutritional regime above will reduce risk of secondary loss of treatment response, and of subsequent disease relapse.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years - 18 Years
- Who can join: All genders
Biomarkers mentioned
Who cannot take part
- ✗Presence of stoma or of short bowel syndrome.
- ✗Patients currently receiving oral or intravenous steroids at a dosage \>20mg/day prednisolone or \>9mg/day budesonide.
- ✗Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background...
- ✗CD with a major fistulising or causing symptoms fibrotic stricturing phenotype.
- ✗Patients with comorbid anorexia nervosa.
See the full criteria
Where Is This Study? (6 UK sites)
The Royal Aberdeen Children's Hospital
Aberdeen AB25 2ZG, United Kingdom
University Hospital Crosshouse
Crosshouse KA2 0BE, United Kingdom
Ninewells Hospital
Dundee DD1 9SY, United Kingdom
Royal Hospital for Children & Young People
Edinburgh EH16 4TJ, United Kingdom
Royal Hospital For Children
Glasgow G51 4TF, United Kingdom
University Hospital Wishaw
Wishaw ML2 0DP, United Kingdom
How to Get in Touch
Konstantinos Gerasimidis, Professor
Sponsor contactCONTACT
Sophie F Morris, BSc (Hons)
Sponsor contactCONTACT