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
Sponsors and collaborators
Vastra Gotaland Region
Lead sponsor
Skane University Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
Göteborg University
Collaborator
Skaraborg Hospital
Collaborator