Biologics plus a 6-week enteral nutrition plan for children with Crohn's disease
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
This will test whether giving children and teens (6–18) with active Crohn's disease a 6-week specialised liquid diet alongside biologic drugs helps them achieve and stay in remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | University of Glasgow Academic / other |
| Drugs / interventions | infliximab, adalimumab, methotrexate |
| Locations | 6 sites (Aberdeen and 5 other locations) |
| Trial ID | NCT07522528 on ClinicalTrials.gov |
What this trial studies
This interventional study will recruit about 90 children and young adults with active Crohn's disease who are starting TNFα inhibitor therapy (infliximab or adalimumab) at six centres across Scotland. Participants will be randomised or allocated by choice to follow either their usual unrestricted diet or an enteral nutrition regimen that replaces varying amounts of their diet for the first 6 weeks of biologic induction. The investigators will compare clinical remission and biomarker normalization after 10–12 weeks and track how many participants remain symptom-free for up to one year. Secondary measures include nutrition and body composition, quality of life, immune profiling, inflammatory cytokines, and gut and oral microbiome composition and function.
Who should consider this trial
Good fit: Children and young adults aged 6–18 with active Crohn's disease (wPCDAI ≥ 12.5 or fecal calprotectin > 250 mg/kg) who are due to start standard-of-care TNFα inhibitor therapy (infliximab or adalimumab).
Not a fit: Patients not initiating TNFα biologic therapy, adults over 18, those unable to tolerate enteral nutrition, or those with medical contraindications are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, adding a 6-week enteral nutrition regimen to biologic induction could increase remission rates and extend symptom-free periods for children with Crohn's disease.
How similar studies have performed: Exclusive enteral nutrition is a proven induction therapy in pediatric Crohn's and biologics have moderate success rates, but combining enteral nutrition with biologic induction has limited trial evidence and is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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). * 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 immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks. * 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. * Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C. * Patients with untreated tuberculosis (latent or active). * Current enrolment in other studies of an investigational product or dietary intervention. * Food allergies, which do not permit participation in the study (e.g., cow's milk allergy). * Pregnant and/or breastfeeding individuals.
Where this trial is running
Aberdeen and 5 other locations
- The Royal Aberdeen Children's Hospital — Aberdeen, United Kingdom (Not_yet_recruiting)
- University Hospital Crosshouse — Crosshouse, United Kingdom (Not_yet_recruiting)
- Ninewells Hospital — Dundee, United Kingdom (Not_yet_recruiting)
- Royal Hospital for Children & Young People — Edinburgh, United Kingdom (Recruiting)
- Royal Hospital For Children — Glasgow, United Kingdom (Recruiting)
- University Hospital Wishaw — Wishaw, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Konstantinos Gerasimidis, Professor
- Email: Konstantinos.Gerasimidis@glasgow.ac.uk
- Phone: +441419560580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.