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

NCT07334340 | Not Yet Recruiting

• 2 other identifiers: 2025-05123-01282814
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Pediatric gastroenterology; Crohn´s Disease; Enteral nutrition; Nutritional therapy; whole food; nordic CDED; CDED

Outcome Measures

Primary Outcomes (1)

• Corticosteroid-free Clinical Remission

  Measured by remission rates: PCDAI ≤10 without systemic steroid use, of the Nordic CDED compared to same outcome from studies of the original CDED in similar paediatric populations and study designs. Tool: PCDAI, a validated tool used to measure the severity of Crohn's disease in children and adolescents by scoring various clinical and laboratory factors Symptoms: Abdominal pain, frequency/consistency of stools, blood in stool. Growth: Weight stability and linear growth (height velocity). Physical Exam: Presence of perianal disease (fistulas, fissures) and extra-intestinal manifestations (arthritis, uveitis, skin issues). Lab Tests: Hemoglobin, hematocrit, ESR (Erythrocyte Sedimentation Rate).

  From enrollment to week 8,14 and 24

Secondary Outcomes (5)

• Corticosteroid-free clinical remission

  At week 8, 14, 20 and 24

• Additional medical treatment

  At week 14 of treatment

• Reduction in Faecal calprotectin

  By week 20 and 24 of the study.

• Adherence to N-CDED diet

  Week 2, 8, 14 and 24

• Modification in quality of life

  Basal, week 8 and 24

Study Arms (1)

Nordic Crohn´s Disease Exclusion Diet

EXPERIMENTAL

2 weeks of total enteral nutrition followed by 3 phases (6 weeks each) of a Nordic Crohn´s Disease Exclusion Diet.

Other: Nordic Crohn´s Disease Exclusion Diet

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 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.

Also known as: N-CDED, Nordic-CDED

Nordic Crohn´s Disease Exclusion Diet

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skane University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Göteborg University: collaborator
• Vastra Gotaland Region: lead
• Skaraborg Hospital: collaborator

Study Sites (3)

Skånes University Hospital

Malmo, Skåne County, 214 28, Sweden

Location

Queen Silvia's Children's and Adolescent Hospital

Gothenburg, 41685, Sweden

Location

Skaraborg Hospital Skövde, Pediatric Clinic

Skövde, 54949, Sweden

Location

Related Publications (19)

• Landorf E, Hammond P, Abu-Assi R, Ellison S, Boyle T, Comerford A, Couper R. Formula modifications to the Crohn's disease exclusion diet do not impact therapy success in paediatric Crohn's disease. J Pediatr Gastroenterol Nutr. 2024 Jun;78(6):1279-1286. doi: 10.1002/jpn3.12215. Epub 2024 Apr 16.

  PMID: 38623960 BACKGROUND

• Urlep D, Benedik E, Brecelj J, Orel R. Partial enteral nutrition induces clinical and endoscopic remission in active pediatric Crohn's disease: results of a prospective cohort study. Eur J Pediatr. 2020 Mar;179(3):431-438. doi: 10.1007/s00431-019-03520-7. Epub 2019 Nov 28.

  PMID: 31781933 BACKGROUND

• Sigall Boneh R, Westoby C, Oseran I, Sarbagili-Shabat C, Albenberg LG, Lionetti P, Manuel Navas-Lopez V, Martin-de-Carpi J, Yanai H, Maharshak N, Van Limbergen J, Wine E. The Crohn's Disease Exclusion Diet: A Comprehensive Review of Evidence, Implementation Strategies, Practical Guidance, and Future Directions. Inflamm Bowel Dis. 2024 Oct 3;30(10):1888-1902. doi: 10.1093/ibd/izad255.

  PMID: 37978895 BACKGROUND

• Vivanco Karlsson N, Sigall-Boneh R, Marild K, Hard Af Segerstad EM. Adapting the Crohn's disease exclusion diet to a Nordic framework: a theoretical approach to cultural and nutritional customization. Front Nutr. 2025 Jun 19;12:1590847. doi: 10.3389/fnut.2025.1590847. eCollection 2025.

  PMID: 40612302 BACKGROUND

• Sigall Boneh R, Park S, Soledad Arcucci M, Herrador-Lopez M, Sarbagili-Shabat C, Kolonimos N, Wierdsma N, Chen M, Hershkovitz E, Wine E, Van Limbergen J. Cultural Perspectives on the Efficacy and Adoption of the Crohn's Disease Exclusion Diet across Diverse Ethnicities: A Case-Based Overview. Nutrients. 2024 Sep 20;16(18):3184. doi: 10.3390/nu16183184.

  PMID: 39339784 BACKGROUND

• Sigall Boneh R, Sarbagili Shabat C, Yanai H, Chermesh I, Ben Avraham S, Boaz M, Levine A. Dietary Therapy With the Crohn's Disease Exclusion Diet is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy. J Crohns Colitis. 2017 Oct 1;11(10):1205-1212. doi: 10.1093/ecco-jcc/jjx071.

  PMID: 28525622 BACKGROUND

• Urlep D, Orel R, Kunstek P, Benedik E. Treatment of Active Crohn's Disease in Children Using Partial Enteral Nutrition Combined with a Modified Crohn's Disease Exclusion Diet: A Pilot Prospective Cohort Trial on Clinical and Endoscopic Outcomes. Nutrients. 2023 Nov 4;15(21):4676. doi: 10.3390/nu15214676.

  PMID: 37960328 BACKGROUND

• Scarallo L, Banci E, De Blasi A, Paci M, Renzo S, Naldini S, Barp J, Pochesci S, Fioretti L, Pasquini B, Cavalieri D, Lionetti P. A real-life pediatric experience of Crohn's disease exclusion diet at disease onset and in refractory patients. J Pediatr Gastroenterol Nutr. 2024 Sep;79(3):592-601. doi: 10.1002/jpn3.12283. Epub 2024 Jul 4.

  PMID: 38962891 BACKGROUND

• Sigall Boneh R, Navas-Lopez VM, Hussey S, Pujol-Muncunill G, Lawrence S, Rolandsdotter H, Otley A, Martin-de-Carpi J, Abramas L, Herrador-Lopez M, Egea Castillo N, Chen M, Hurley M, Wingate K, Olen O, Eurenius Raaf T, Yaakov M, Wierdsma N, Van Limbergen J, Wine E. Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease: Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Oct;23(11):2001-2011. doi: 10.1016/j.cgh.2024.12.006. Epub 2024 Dec 26.

  PMID: 39732356 BACKGROUND

• Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110.

  PMID: 24983973 BACKGROUND

• Barros VJDS, Severo JS, Mendes PHM, da Silva ACA, de Oliveira KBV, Parente JML, Lima MM, Neto EMM, Aguiar Dos Santos A, Tolentino Bento da Silva M. Effect of dietary interventions on inflammatory biomarkers of inflammatory bowel diseases: A systematic review of clinical trials. Nutrition. 2021 Nov-Dec;91-92:111457. doi: 10.1016/j.nut.2021.111457. Epub 2021 Aug 18.

  PMID: 34583136 BACKGROUND

• Gkikas K, Logan M, Nichols B, Ijaz UZ, Clark CM, Svolos V, Gervais L, Duncan H, Garrick V, Curtis L, Buchanan E, Cardigan T, Armstrong L, Delahunty C, Flynn DM, Barclay AR, Tayler R, Milling S, Hansen R, Russell RK, Gerasimidis K. Dietary triggers of gut inflammation following exclusive enteral nutrition in children with Crohn's disease: a pilot study. BMC Gastroenterol. 2021 Dec 3;21(1):454. doi: 10.1186/s12876-021-02029-4.

  PMID: 34861829 BACKGROUND

• Malmborg P. IBD - Vårdprogram Inflammatorisk tarmsjukdom hos barn och ungdomar (IBD - Care program Inflammatory bowel disease in children and adolescents). In: Svenska Föreningen för Pediatrisk Gastroenterologi HoN-SSAfPG, Hepatology and Nutrition), editor. 2024. p. 21-3.

  BACKGROUND

• van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S, Kolho KL, Levine A, van Limbergen J, Martin de Carpi FJ, Navas-Lopez VM, Oliva S, de Ridder L, Russell RK, Shouval D, Spinelli A, Turner D, Wilson D, Wine E, Ruemmele FM. The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis. 2021 Feb 1;15(2):jjaa161. doi: 10.1093/ecco-jcc/jjaa161. Epub 2020 Oct 7.

  PMID: 33026087 BACKGROUND

• Swaminath A, Feathers A, Ananthakrishnan AN, Falzon L, Li Ferry S. Systematic review with meta-analysis: enteral nutrition therapy for the induction of remission in paediatric Crohn's disease. Aliment Pharmacol Ther. 2017 Oct;46(7):645-656. doi: 10.1111/apt.14253. Epub 2017 Aug 16.

  PMID: 28815649 BACKGROUND

• de Bie C, Kindermann A, Escher J. Use of exclusive enteral nutrition in paediatric Crohn's disease in The Netherlands. J Crohns Colitis. 2013 May;7(4):263-70. doi: 10.1016/j.crohns.2012.07.001. Epub 2012 Jul 21.

  PMID: 22820027 BACKGROUND

• Whelan K, Murrells T, Morgan M, Cummings F, Stansfield C, Todd A, Sebastian S, Lobo A, Lomer MCE, Lindsay JO, Czuber-Dochan W. Food-related quality of life is impaired in inflammatory bowel disease and associated with reduced intake of key nutrients. Am J Clin Nutr. 2021 Apr 6;113(4):832-844. doi: 10.1093/ajcn/nqaa395.

  PMID: 33677550 BACKGROUND

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  PMID: 29050646 BACKGROUND

• Levine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.

  PMID: 31170412 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Stine Störsrud, RD, PhD

  Dept of Molecular & Clinical Medicine, Sahlgrenska Academy, Univ of Gothenburg, Sweden

  STUDY CHAIR

• Elin Malmgren Hård af Segerstad, Ped Diet, PhD

  Pediatric Research Institute, Oslo Univ Hosp, Norway; Clinical Sciences, Lund Univ, Malmö, Sweden

  STUDY CHAIR

• Karl Mårild, MD, PhD

  Dept of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg

  STUDY DIRECTOR

• Nalleli Vivanco Karlsson, Ped Diet, PhD

  Dept of Pediatrics, Skaraborg Hosp, Skövde, Sweden; Sahlgrenska Academy, Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nalleli Vivanco Karlsson, Ped Diet, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)