ClinicaliQ Trial Snapshot
- Biologics and Paediatric Enteral Nutrition in Crohn’s Disease Study — Recruiting • Non-phase study • Respiratory / COPD / Asthma • NCT07522528.
- What is being tested: This study evaluates the effectiveness and safety of biologic medications (injectable drugs targeting inflammation) compared to enteral nutrition therapy (specialised liquid diet) in paediatric patients with Crohn's disease who have not responded to standard treatments.
- Patient eligibility overview: The trial focuses on children and young people with Crohn's disease whose condition has proven resistant to conventional therapies, representing a population with limited treatment options and significant unmet clinical need.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.