NCT07211789Completed
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 58 (actual)
- First submitted
- 1 Oct 2025
- Start date
- Feb 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- Outcomes'10
- Diseases
- Crohn's disease
- NCT number
- NCT07211789
What you commit to
- Study type: Observational
- Participants enrolled: 58
- From Feb 2024 to the primary completion date, Aug 2025
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with ulcerative colitis and/or unclassified inflammatory bowel disease.
- Patients with more than 36 months of disease progression.
- Active perianal disease.
Other
- Penetrating (B3) and/or non-inflammatory stenosing (B2) pattern.
- Presence of extraintestinal manifestations.
Who the study is looking for
- 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.
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital Torrecardenas Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| Hospital Univeristari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Sant Joan de Déu Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario Materno-Infantil de Canarias de Las Palmas Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Universitario Niño Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Materno Infantil Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Central Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario de Nuestra Señora de la Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Complejo Hospitalario Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.