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

Starting soon · Not applicable

Conditions studied: Pediatric Crohns Disease

In brief

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

Key facts

Study ID

NCT07334340

Run by

Vastra Gotaland Region

People needed

30

Starts

2026-02-01

Expected to finish

2030-01-01

Last updated by the study team

2026-01-12

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Eating disorders,
• Active extraintestinal manifestations
• Use of systemic corticosteroids
• Active perianal disease
• Positive stool cultures for pathogens, parasites, or Clostridioides difficile
• Fever >38.3°C
• Documented cow's milk protein allergy
• Diabetes, celiac disease and/or psychosocial difficulties.

Where it is running

• Skånes University Hospital — Malmö, Skåne County, Sweden
• Queen Silvia's Children's and Adolescent Hospital — Gothenburg, Sweden
• Skaraborg Hospital Skövde, Pediatric Clinic — Skövde, Sweden

Full record on ClinicalTrials.gov

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