NCT07334340Not yet recruiting
Modified vs Standard CDED: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Disease
Modified vs Standard Crohn´s Disease Exclusion Diet: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Diseas
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Crohn's disease
- NCT number
- NCT07334340
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Feb 2026 to the primary completion date, 1 Jan 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic corticosteroids
Other illness
- Eating disorders,
- Active perianal disease
- Documented cow's milk protein allergy
- Diabetes, celiac disease and/or psychosocial difficulties.
Other
- Active extraintestinal manifestations
- Positive stool cultures for pathogens, parasites, or Clostridioides difficile
- Fever \>38.3°C
Who the study is looking for
- 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.
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Silvia's Children's and Adolescent Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Skånes University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Skaraborg Hospital Skövde, Pediatric Clinic Coordinator of this site? Confirm its status | Skövde | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.