Status:
COMPLETED
Real World Evidence Study With Restrictive Diet and Otral Nutritional Supplementation on Pediatric Patients With Active Chron Disease
Lead Sponsor:
Outcomes'10
Collaborating Sponsors:
Nestlé Health Science Spain
Conditions:
Crohn Disease
Eligibility:
All Genders
8-18 years
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT07211789
Start Date
February 1 2024
End Date
August 15 2025
Last Update
October 8 2025
Active Locations (15)
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1
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
2
Hospital Torrecárdenas
Almería, Spain
3
Hospital Sant Joan de Déu
Barcelona, Spain
4
Hospital Univeristari Vall d'Hebron
Barcelona, Spain