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Can a diet tame Crohn's in kids? new study says yes

NCT ID NCT07211789

Disease control Sponsor: Outcomes'10 Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a special diet (called CDED plus NEP) works for children aged 8 to 18 with active Crohn's disease. The diet aims to reduce inflammation and help the gut heal without needing steroids or other strong drugs. Researchers tracked 58 kids in real-world clinics to see if the diet could bring remission and improve quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

58 people

The number who actually took part.

Started

Feb 2024

Finished

Aug 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

8 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease Pediatric Crohn's disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

Contacts and locations

Locations

  • Complejo Hospitalario Universitario de Albacete

    Albacete, Spain

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, Spain

  • Hospital Sant Joan de Déu

    Barcelona, Spain

  • Hospital Torrecárdenas

    Almería, Spain

  • Hospital Univeristari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Central

    Oviedo, Spain

  • Hospital Universitario Materno Infantil

    Málaga, Spain

  • Hospital Universitario Materno-Infantil de Canarias de Las Palmas

    Las Palmas de Gran Canaria, Spain

  • Hospital Universitario Niño Jesús

    Madrid, Spain

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, Spain

  • Hospital Universitario de Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, Spain

  • Hospital Universitario la Fe

    Valencia, Spain

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