Modified vs Standard CDED: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorVastra Gotaland Region

About this trial

The primary aim of this clinical trial is to evaluate the clinical effectiveness of the Nordic Crohn's Disease Exclusion Diet (Nordic CDED) in children with Crohn's disease, measured by remission rates, and to compare these outcomes with those reported for the original CDED in similar pediatric populations and study designs.

The secondary objectives are to assess whether the Nordic CDED can facilitate greater individualization of the diet, improve treatment adherence, and enhance quality of life.

The study seeks to answer the following key questions:

* Does the Nordic CDED achieve the same clinical effectiveness as the original CDED? * Does the Nordic CDED improve adherence and quality of life in children with Crohn's disease? To address these questions, researchers will compare outcomes from children following the Nordic CDED with published results from similar studies of the original CDED, as well as with patients who were not treated with a dietary intervention.

Participant Involvement:

* Follow the Nordic CDED for 20 weeks. * Attend clinic visits at weeks 2, 8, 14, 20, and 24 for checkups and tests. * Report adherence to the diet through food records. * Report quality of life at the beginning and end of the study

Eligibility criteria

Qualifiers

Children aged 6-18 years with recent (<36 months) mild-to-severe CD diagnosis (defined as Paediatric Crohn's Disease Activity Index [PCDAI] 15-47.5)

Evidence of active inflammation (C-reactive protein [CRP] ≥ 0.5 mg/dL, erythrocyte sedimentation rate [ESR] ≥ 20 mm/h, and/or faecal calprotectin [FCP] ≥ 200 mg/g during screening)

Stable use of medication other than steroids.

Disqualifiers

Eating disorders,

Active extraintestinal manifestations

Use of systemic corticosteroids

Active perianal disease

Trial design

Treatments tested in this trial

  • Nordic Crohn´s Disease Exclusion Diet

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Vastra Gotaland Region

Lead sponsor

Skane University Hospital

Collaborator

Sahlgrenska University Hospital

Collaborator

Göteborg University

Collaborator

Skaraborg Hospital

Collaborator