NCT07211789

Real World Evidence Study With Restrictive Diet and Otral Nutritional Supplementation on Pediatric Patients With Active Chron Disease

Real World Evidence en Pacientes pediátricos Con Enfermedad de Crohn Activa

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 58 (actual)
• Sponsor: Outcomes'10 · Network
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective study aims to provide real-world evidence of the effectiveness of the NEP + CDED diet in paediatric patients with Crohn's disease under conditions of routine clinical practice.

Detailed description

Pediatric Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract that impacts growth and quality of life. Exclusive enteral nutrition (EEN) is the standard dietary treatment to induce remission, although its use is limited by low acceptability and strict dietary restrictions. The combination of partial enteral nutrition (PEN) with the Crohn's Disease Exclusion Diet (CDED) represents a more tolerable alternative that reduces exposure to harmful dietary components and has shown efficacy in inducing clinical remission in previous studies. This observational, prospective, multicenter study will evaluate the effectiveness of CDED+PEN in routine clinical practice in pediatric patients (8-18 years) with active Crohn's disease. The primary objective is to assess the proportion of patients achieving clinical remission (wPCDAI ≤ 12.5) and mucosal healing (MINI Index \< 8), steroid-free at weeks 6, 12, and 24, and anti-TNF-free at week 24. Secondary objectives include assessing health-related quality of life (IMPACT-III), treatment satisfaction and gastrointestinal tolerance, treatment persistence, and estimation of healthcare resource utilization and associated costs. The study is observational, descriptive, and non-interventional with respect to drugs, and will be conducted in pediatric patients initiating CDED+PEN as part of standard clinical care. Treatment prescription will be independent of study participation, and patients who receive the indication may be invited to participate after providing informed consent together with their parents or legal guardians. Primary outcome measures include the frequency of patients in steroid-free clinical remission at weeks 6, 12, and 24, anti-TNF-free remission at week 24, and the proportion achieving mucosal healing (MINI Index \< 8) at the same time points. Secondary analyses will include quality of life scores (IMPACT-III), distribution of questionnaire responses on satisfaction and tolerance, treatment persistence assessed by survival analysis, and cost estimates based on healthcare resource use. This study will provide real-world evidence on the effectiveness, acceptability, and sustainability of the dietary approach with CDED+PEN in pediatric Crohn's disease under routine clinical practice conditions.

Conditions

• Crohn Disease

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

15 sites across 1 country: Spain