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Modified vs Standard CDED: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Disease
Sponsor: Vastra Gotaland Region
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
Official title: Modified vs Standard Crohn´s Disease Exclusion Diet: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Diseas
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-02-01
Completion Date
2030-01-01
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Nordic Crohn´s Disease Exclusion Diet
The 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.
Locations (3)
Skånes University Hospital
Malmo, Skåne County, Sweden
Queen Silvia's Children's and Adolescent Hospital
Gothenburg, Sweden
Skaraborg Hospital Skövde, Pediatric Clinic
Skövde, Sweden