Modified vs Standard CDED: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Disease
Not applicable · Testing Nordic Crohn´s Disease Exclusion Diet · 3 sites · Vastra Gotaland Region
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Nordic Crohn´s Disease Exclusion Diet as a possible treatment. Condition(s) listed: Pediatric Crohns Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 6 to 18
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2026-02-01 (planned).
- Main results expected around 2029-01-01 (estimate from the record).
- 3 study sites listed in Sweden.
Main thing being measured
- Corticosteroid-free Clinical Remission (From enrollment to week 8,14 and 24)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Pediatric Crohns Disease |
| Lead sponsor | Vastra Gotaland Region |
| Collaborators | Skane University Hospital; Sahlgrenska University Hospital; Göteborg University; Skaraborg Hospital |
| Enrollment | 30 (estimated) |
| Start date | 2026-02-01 |
| Primary completion (est.) | 2029-01-01 |
| First posted | 2026-01-12 |
| Last updated | 2026-01-12 |
| Official title | Modified vs Standard Crohn´s Disease Exclusion Diet: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Diseas |
| ClinicalTrials.gov ID | NCT07334340 |
Interventions
- Nordic Crohn´s Disease Exclusion Diet (Other)
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 ingredient…
Full eligibility criteria (from the record)
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.
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Silvia's Children's and Adolescent Hospital | Gothenburg | Sweden | |
| Skaraborg Hospital Skövde, Pediatric Clinic | Skövde | Sweden | |
| Skånes University Hospital | Malmö, Skåne County | Sweden |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.