Not Yet RecruitingNot Applicable

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

Sweden30 participantsStarted 2026-02-01

Plain-language summary

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

Who can participate

Age range6 Years – 18 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Corticosteroid-free Clinical Remission

Timeframe: From enrollment to week 8,14 and 24

Trial details

NCT IDNCT07334340

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

Nalleli Vivanco Karlsson, Ped Diet, PhD

+46 70 412 7142 nalleli.vivanco.karlsson@vgregion.se