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
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.
Eating disorders,
Active extraintestinal manifestations
Use of systemic corticosteroids
Active perianal disease
Single group
Nordic Crohn´s Disease Exclusion Diet
Other interventionThe study consists of 20 weeks of dietary intervention, divided into four phases, followed by a 4-week follow-up period. The intervention begins with a 2-week period of liquid nutrition, after which unprocessed foods are gradually introduced while liquid nutrition is progressively reduced over three consecutive 6-week phases. The diet is specifically designed to exclude pro-inflammatory ingredients and emphasize gut-friendly foods. In the final phase, participants are allowed consume most unprocessed foods, along with up to two meals per week containing products with food additives.
Corticosteroid-free Clinical Remission
Measured by remission rates: PCDAI ≤10 without systemic steroid use, of the Nordic CDED compared to same outcome from studies of the original CDED in similar paediatric populations and study designs. Tool: PCDAI, a validated tool used to measure the severity of Crohn's disease in children and adolescents by scoring various clinical and laboratory factors Symptoms: Abdominal pain, frequency/consistency of stools, blood in stool. Growth: Weight stability and linear growth (height velocity). Physical Exam: Presence of perianal disease (fistulas, fissures) and extra-intestinal manifestations (arthritis, uveitis, skin issues). Lab Tests: Hemoglobin, hematocrit, ESR (Erythrocyte Sedimentation Rate).
Corticosteroid-free clinical remission
PCDAI \< 10
Additional medical treatment
Any treatment changed by physician discretion besides immunomodulator (e.g., biologics, steroids).
Reduction in Faecal calprotectin
≥50% reduction of faecal calprotectin compared to basal concentration.
Adherence to N-CDED diet
Dietary adherence evaluated by: Food Frequency Questionnaire: Validated interactive web-based questionnaires for assessing diet quality. 24 hour and 3 days food diary recall Modified MARS compliance questionnaire: A questionnaire developed to evaluate compliance to the enteral nutrition and CDED diet. 5-point Likert Scale: A questionnaire developed to evaluate compliance to the diet therapy.
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Vastra Gotaland Region
Lead sponsor
Skane University Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
Göteborg University
Collaborator
Skaraborg Hospital
Collaborator
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