The Crohn's Disease Exclusion Diet With Early Dairy Introduction vs Partial Enteral Nutrition for Crohn's Disease

NCT05606419 | Suspended DMC

• 1 other identifier: 605/16-12-2021
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate a novel diet for adult Crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Some of the patients in this study will receive the CDED combined with partial enteral nutrition (PEN), while the other group will receive the CDED with early introduction of dairy products, that were eliminated from the initial CDED protocol.

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Diseases; Diet therapy; Crohn's Disease; Enteral Nutrition; Partial Enteral Nutrition; Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

• Clinical response - Change in Harvey Bradshaw Index (HBI)

  Higher HBI scores indicate worse outcomes. Clinical response is defined as baseline HBI score decrease of ≥ 3, and clinical remission is defined as score \<5

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (13)

• Faecal calprotectin

  Baseline, 6 weeks, 12 weeks

• Change in serum CRP

  Baseline, 6 weeks, 12 weeks

• Change in serum Albumin

  Baseline, 6 weeks, 12 weeks

• Bowel symptoms improvement

  Baseline, 6 weeks, 12 weeks

• Health Related Quality of Life (HR-QoL)

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

CDED + PEN

EXPERIMENTAL

Crohn's Disease Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN): Patients will follow the first phase diet (CDED+50%PEN) for 6 weeks and will continue with CDED phase 2 + 25%PEN for another 6 weeks. Total duration: 12 weeks.

Dietary Supplement: CDED+PEN

CDED + Dairy

ACTIVE COMPARATOR

Crohn's Disease Exclusion Diet (CDED) + dairy products: Patients will follow the first phase diet CDED + 50% of their energy requirements covered by dairy products for 6 week and then will continue with the CDED phase 2 diet + 25% dairy products.

Dietary Supplement: CDED+dairy

Interventions

CDED+PEN DIETARY_SUPPLEMENT

Dietary intervention (Liquid food replacement intervention and specific exclusion diet). Focus on 24 hour diet recalls to asses adherence.

CDED + PEN

CDED+dairy DIETARY_SUPPLEMENT

Dietary intervention (Specific exclusion diet plus early dairy introduction). Focus on 24 hour diet recalls to asses adherence.

CDED + Dairy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have an established diagnosis of CD
• Participants must have clinically active disease defined as HBI ≥ 5
• Participants must have confirmed inflammation at screening as CRP \> 5 mg/L, FC \>100 mg/g, or presence of inflammation on endoscopy in the 3 months before screening based on retrospective review of procedure reports by the local investigator and the clinician's assessment
• Individuals able to give informed consent and willingness to participate

You may not qualify if:

• Age \< 18 years old
• Previous extensive bowel resection
• Reported pregnancy or lactation
• Current stoma
• Current abscess
• Clinically significant stricture
• Introduction of or change in dose of drug therapy within the past 8 weeks
• Comorbidities including diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological, cardiovascular, neoplastic or other autoimmune disease
• Food allergies or intolerances, which do not permit participation in the study
• Any proven current infection such as positive stool cultures or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.

Sponsors & Collaborators

• Evangelismos Hospital: lead
• Agricultural University of Athens: collaborator

Study Sites (1)

Evangelismos General Hospital of Athens

Athens, Attica, 10676, Greece

Location

Related Publications (8)

• Gkikas K, Gerasimidis K, Milling S, Ijaz UZ, Hansen R, Russell RK. Dietary Strategies for Maintenance of Clinical Remission in Inflammatory Bowel Diseases: Are We There Yet? Nutrients. 2020 Jul 7;12(7):2018. doi: 10.3390/nu12072018.

  PMID: 32645980 BACKGROUND

• Levine A, Sigall Boneh R, Wine E. Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases. Gut. 2018 Sep;67(9):1726-1738. doi: 10.1136/gutjnl-2017-315866. Epub 2018 May 18.

  PMID: 29777041 BACKGROUND

• Bischoff SC, Escher J, Hebuterne X, Klek S, Krznaric Z, Schneider S, Shamir R, Stardelova K, Wierdsma N, Wiskin AE, Forbes A. ESPEN practical guideline: Clinical Nutrition in inflammatory bowel disease. Clin Nutr. 2020 Mar;39(3):632-653. doi: 10.1016/j.clnu.2019.11.002. Epub 2020 Jan 13.

  PMID: 32029281 BACKGROUND

• Wall CL, Day AS, Gearry RB. Use of exclusive enteral nutrition in adults with Crohn's disease: a review. World J Gastroenterol. 2013 Nov 21;19(43):7652-60. doi: 10.3748/wjg.v19.i43.7652.

  PMID: 24282355 BACKGROUND

• Logan M, Clark CM, Ijaz UZ, Gervais L, Duncan H, Garrick V, Curtis L, Buchanan E, Cardigan T, Armstrong L, Delahunty C, Flynn DM, Barclay AR, Tayler R, McDonald E, Milling S, Hansen RK, Gerasimidis K, Russell RK. The reduction of faecal calprotectin during exclusive enteral nutrition is lost rapidly after food re-introduction. Aliment Pharmacol Ther. 2019 Sep;50(6):664-674. doi: 10.1111/apt.15425. Epub 2019 Jul 25.

  PMID: 31342536 BACKGROUND

• Yang H, Feng R, Li T, Xu S, Hao X, Qiu Y, Chen M. Systematic review with meta-analysis of partial enteral nutrition for the maintenance of remission in Crohn's disease. Nutr Res. 2020 Sep;81:7-18. doi: 10.1016/j.nutres.2020.06.006. Epub 2020 Jun 9.

  PMID: 32798791 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

• Yanai H, Levine A, Hirsch A, Boneh RS, Kopylov U, Eran HB, Cohen NA, Ron Y, Goren I, Leibovitzh H, Wardi J, Zittan E, Ziv-Baran T, Abramas L, Fliss-Isakov N, Raykhel B, Gik TP, Dotan I, Maharshak N. The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):49-59. doi: 10.1016/S2468-1253(21)00299-5. Epub 2021 Nov 2.

  PMID: 34739863 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dimitrios Karayiannis, Dr.

  Evangelismos General Hospital of Athens

  PRINCIPAL INVESTIGATOR

• Kalliopi Anna Poulia, Dr.

  Agricultural University of Athens

  STUDY DIRECTOR

• Gerasimos Mantzaris, Dr.

  Evangelismos General Hospital of Athens

  STUDY CHAIR

• Nikos Viazis, Dr.

  Evangelismos General Hospital of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Dietitian-Nutritionist

Model Details: Patients with mildly active disease will follow either the CDED diet protocol (CDED + PEN) or the CDED diet with dairy products included, for up to12 weeks. All participants will attend study visits at the beginning, in the middle and at end of the trials, at which points questionnaires will be completed and samples will be collected.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 4, 2022
• Study Start: March 10, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)