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

NCT07211789 | Completed

• 1 other identifier: NES-2019-050-OBS-CROHN
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Disease; Pediatric Crohn's Disease; Children; Pediatrics; Observational Study; Multicenter Study; Prospective Study; Quality of Life; exclusion diet; wPCDAI; MINI index

Outcome Measures

Primary Outcomes (3)

• Effectiveness of the CDED + NEP

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

  Weeks 6, 12, 24

• Effectiveness of the CDED + NEP

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

  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.

  Weeks 6, 12, 24

Secondary Outcomes (5)

• Health-related quality of life

  Weeks 6, 12, 24

• Satisfaction and acceptability with nutritional treatment

  Weeks 6, 12, 24

• Gastrointestinal tolerance

  Weeks 6, 12, 24

• Persistence with the diet

  Weeks 6, 12, 24

• Healthcare resource use and associated costs

  Weeks 6, 12, 24

Study Arms (1)

Patients aged 8-18 years with Crohn's disease initiating treatment with EEN+CDED

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 8-18 years with Crohn's disease initiating treatment with exclusive enteral nutrition (EEN) plus the Crohn's Disease Exclusion Diet (CDED) and whose wPCDAI value is equal to or greater than 12.5.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Outcomes'10: lead
• Nestlé Health Science Spain: collaborator

Study Sites (15)

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

Location

Hospital Torrecárdenas

Almería, Spain

Location

Hospital Sant Joan de Déu

Barcelona, Spain

Location

Hospital Univeristari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hospital Universitario Materno-Infantil de Canarias de Las Palmas

Las Palmas de Gran Canaria, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Niño Jesús

Madrid, Spain

Location

Hospital Universitario Materno Infantil

Málaga, Spain

Location

Hospital Universitario Central

Oviedo, Spain

Location

Hospital Universitario de Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario la Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Pediatric Crohn's disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: February 1, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)