NCT07522528Recruiting
Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 24 Mar 2026
- Start date
- 27 Mar 2026
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- University of Glasgow
- Diseases
- Crohn's disease
- NCT number
- NCT07522528
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 27 Mar 2026 to the primary completion date, 31 Aug 2030
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks.
- Current enrolment in other studies of an investigational product or dietary intervention.
Other illness
- Presence of stoma or of short bowel syndrome.
- Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C.
- Patients with untreated tuberculosis (latent or active).
- Food allergies, which do not permit participation in the study (e.g., cow's milk allergy).
Age
- Inability to provide consent to participate in the study (i.e., this applies to young adults (aged 16-18 years) who are old enough but unable to provide consent and carers (of children aged 6-15 years old) who are unable to provide consent on behalf of their child).
Other
- CD with a major fistulising or symptomatic fibrotic stricturing phenotype.
- Patients with comorbid anorexia nervosa.
- Any clinical contraindication to use of exclusive enteral nutrition or partial enteral nutrition.
- Pregnant and/or breastfeeding individuals.
Who the study is looking for
- Eligible participants to the RCT are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \>250 mg/kg and who have a clinical indication to initiate standard of care induction treatment with TNFα inhibitors (infliximab or adalimumab).
- Eligible participants to the observational cohorts are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \>250 mg/kg and who are due to initiate standard of care induction treatment with EEN therapy alongside TNFα inhibitors (infliximab or adalimumab) or standard of care induction treatment with EEN therapy without TNFα inhibitors (infliximab or adalimumab)
Age in the registry: 6 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Aberdeen Children's Hospital Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Not yet recruiting |
| University Hospital Crosshouse Coordinator of this site? Confirm its status | Crosshouse | United Kingdom | Not yet recruiting |
| Ninewells Hospital Coordinator of this site? Confirm its status | Dundee | United Kingdom | Not yet recruiting |
| Royal Hospital for Children & Young People Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Royal Hospital for Children Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| University Hospital Wishaw Coordinator of this site? Confirm its status | Wishaw | United Kingdom | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.