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

Outcomes'1058 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn Disease

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Crohn's disease (diagnosis based on clinical, laboratory, endoscopic, radiological, and histological criteria, according to the revised Porto criteria of the ESPGHAN for the diagnosis of inflammatory bowel disease in children and adolescents); * Aged between 8 and 18 years; * Who are about to start treatment with NEP + CDED, i.e. CDED-naive patients who may have previously received treatment with NEE; * With active Crohn's disease defined by the Weighted Paediatric Crohn's Disease Activity Index (wPCDAI) ≥ 12.5; * With data collection available for the following 6 months; * Able to follow the study protocol or whose parent/caregiver is able to adhere to the study protocol, according to the investigator's perspective. Exclusion Criteria: * Patients with ulcerative colitis and/or unclassified inflammatory bowel disease. * Patients with more than 36 months of disease progression. * Penetrating (B3) and/or non-inflammatory stenosing (B2) pattern. * Active perianal disease. * Presence of extraintestinal manifestations. * Patients who, in the investigator's opinion, will require surgical treatment or initiation of steroids or biological drugs (anti-TNF, vedolizumab or ustekinumab) within the next 3 months and for whom nutritional support is indicated exclusively as a bridge. Patients who are undergoing biological treatment but discontinue treatment due to non-response and initiate CDED+NEP are not excluded.

Locations (15)

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

Hospital Torrecárdenas

Almería, Spain

Hospital Sant Joan de Déu

Barcelona, Spain

Outcomes

Primary Outcomes

Effectiveness of the CDED + NEP

Measurement of absolute and relative frequencies of patients in steroid-free remission

Time frame: Weeks 6, 12, 24

Effectiveness of the CDED + NEP

Measurement of absolute and relative frequencies of patients in anti-TNF-free remission

Time frame: At week 24

Mucosal healing

The relative and absolute frequencies of patients who have obtained a score of \<8 on the MINI Index will be calculated; this value implies healing of the mucosa.

Time frame: Weeks 6, 12, 24

Secondary Outcomes

Health-related quality of life

The scores obtained with the HRQoL questionnaire will be calculated

Time frame: Weeks 6, 12, 24

Satisfaction and acceptability with nutritional treatment

Based on the distribution of responses to the questionnaire items

Time frame: Weeks 6, 12, 24

Gastrointestinal tolerance

Distribution of responses to questionnaire items

Time frame: Weeks 6, 12, 24

Persistence with the diet

Percentage of patients who persist with the diet at

Time frame: Weeks 6, 12, 24

Healthcare resource use and associated costs

It will be calculated: * Number of visits to professionals who treat the patient (specialist in gastroenterology and paediatric nutrition, primary care, nursing, educational psychologist, social worker, dietitian/nutritionist) * Number of visits to the emergency room per month, * Number of days hospitalised per month, * Number of complementary tests per month, * Number of days of sick leave taken by the caregiver per month, * Number of school days missed per month. For each patient, the monthly cost associated with the use of resources will be estimated by multiplying the frequency of use per month of each resource by its unit cost. Unit costs will be extracted from eSalud.

Data from ClinicalTrials.gov

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