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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
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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complejo Hospitalario Universitario de Albacete
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AlbaceteSpainUnknown status
Hospital Torrecardenas
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AlmeríaSpainUnknown status
Hospital Univeristari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Sant Joan de Déu
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BarcelonaSpainUnknown status
Hospital Universitario Virgen de la Arrixaca
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El PalmarSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Universitario Materno-Infantil de Canarias de Las Palmas
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Las Palmas de Gran CanariaSpainUnknown status
Hospital Universitario Niño Jesus
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario Materno Infantil
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MálagaSpainUnknown status
Hospital Universitario Central
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OviedoSpainUnknown status
Hospital Universitario de Nuestra Señora de la Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Complejo Hospitalario Universitario de Santiago
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Universitario la Fe
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ValenciaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.