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

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

Conditions

• Pediatric Crohns Disease

Interventions

OTHER

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.

Sponsors & Collaborators

• Skane University Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Skaraborg Hospital

  collaborator OTHER_GOV

• Vastra Gotaland Region

  lead OTHER_GOV

Principal Investigators

• Stine Störsrud, RD, PhD · Dept of Molecular & Clinical Medicine, Sahlgrenska Academy, Univ of Gothenburg, Sweden

• Elin Malmgren Hård af Segerstad, Ped Diet, PhD · Pediatric Research Institute, Oslo Univ Hosp, Norway; Clinical Sciences, Lund Univ, Malmö, Sweden

• Karl Mårild, MD, PhD · Dept of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg

• Nalleli Vivanco Karlsson, Ped Diet, PhD · Dept of Pediatrics, Skaraborg Hosp, Skövde, Sweden; Sahlgrenska Academy, Gothenburg

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2029-01-01

Completion

2030-01-01

Countries

• Sweden

Study Locations