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

NCT ID: NCT05606419

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-10
• Study Completion Date: 2026-09-30

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.

Detailed Description

Crohn's disease (CD) is a chronic relapsing inflammatory bowel disease that has a significant impact on patients' quality of life and is of increased incidence worldwide. The disease aetiology is complex and not fully understood. Accumulated data indicate that environmental factors, including diet, might play a key role in the pathogenesis and inflammation, through mechanisms involving gut dysbiosis, in genetically susceptible people. Epidemiological data suggest that a Mediterranean dietary pattern is associated with decreased risk for CD, whereas a Western diet, rich in animal fat, processed foods and food additives, seems to be linked with an increased disease risk.

Exclusive Enteral Nutrition (EEN) is the only well-established dietary therapy in CD and is used as the first line therapy for the induction of remission in mild to moderate pediatric CD. Evidence according to EEN efficacy in adults is not consistent, which could partly be explained by the compliance difficulty. It is of interest, that feacal inflammation increases rapidly after food re-introduction following EEN in children. Partial enteral nutrition (PEN) has been shown to be beneficial in maintaining remission, but poor compliance due to low formula palatability and patients' fatigue remains an important barrier in the clinical practice. Moreover, PEN is inferior to EEN in inducing remission. Crohn's Disease Exclusion Diet (CDED), which eliminates specific dietary components hypothesized to induce dysbiosis, appears to be effective in inducing and maintaining remission both in pediatric and adult populations. In parallel, patients express a strong interest in ways to manage their disease through diet, so the establishment of a palatable and as flexible as possible dietary pattern, not merely for inducing remission, but also as a feasible maintenance strategy is one of the main priorities in CD research at present.

Therefore, the aim of this study is to explore the effectiveness of the CDED and PEN in both inducing and maintaining remission of CD in adults. The investigators also wish to challenge patients with an early exposure to dairy products, to assess tolerability, prospecting for the development of a more flexible dietary approach based on the CDED principles. The investigators aim to assess the intervention effect on CD activity, based on routinely used clinical indices, blood and faecal inflammatory biomarkers (CRP, FC), health-related quality of life, nutritional status and dietary intake, in patients with mildly active CD.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CDED + PEN

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.

Group Type: EXPERIMENTAL

CDED+PEN

Intervention Type: DIETARY_SUPPLEMENT

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

CDED + Dairy

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.

Group Type: ACTIVE_COMPARATOR

CDED+dairy

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

CDED+PEN

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

Intervention Type: DIETARY_SUPPLEMENT

CDED+dairy

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agricultural University of Athens

OTHER

Sponsor Role: collaborator

Evangelismos Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Karayiannis

Chief Dietitian-Nutritionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitrios Karayiannis, Dr.

Role: PRINCIPAL_INVESTIGATOR

Evangelismos General Hospital of Athens

Kalliopi Anna Poulia, Dr.

Role: STUDY_DIRECTOR

Agricultural University of Athens

Gerasimos Mantzaris, Dr.

Role: STUDY_CHAIR

Evangelismos General Hospital of Athens

Nikos Viazis, Dr.

Role: STUDY_CHAIR

Evangelismos General Hospital of Athens

Locations

Evangelismos General Hospital of Athens

Athens, Attica, Greece

Countries

Greece

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Informed Consent Form

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Other Identifiers

605/16-12-2021

Identifier Type: -

Identifier Source: org_study_id