The Crohn's Disease Exclusion Diet With Early Dairy Introduction Plus Partial Enteral Nutrition for Crohn's Disease (CD-EDEN)

May 8, 2023 updated by: Dimitrios Karayiannis, Evangelismos Hospital

The Crohn's Disease Exclusion Diet With Early Dairy Introduction Plus Partial Enteral Nutrition (CD-EDEN) in Adult Patients With Crohn's Disease

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), the other group will receive PEN along with the usual nutritional care and the third group will follow the CDED with early introduction of dairy products, that were eliminated from the initial CDED protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 10676
        • Recruiting
        • Evangelismos General Hospital of Athens
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have an established diagnosis of CD
  • Participants must be in active disease, defined by either the confirmed inflammation at screening as CRP >5 mg/L, FC >200 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 stenosis or 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: CDED+PEN
Dietary intervention (Liquid food replacement intervention and specific exclusion diet). Focus on 24 hour diet recalls to asses adherence.
Active Comparator: Usual Nutritional Care + PEN
Partial Enteral Nutrition (PEN) + usual nutritional care: Patients will be given PEN plus the usual advice for a healthy dietary pattern. PEN will cover the 50% of total energy requirements for the first 6 weeks. During the second 6 weeks, PEN will cover the 25% of the total energy requirements.Total duration: 12 weeks
Dietary supplement: PEN+usual care
Liquid food replacement intervention and regular diet. Focus on 24 hour diet recalls and FFQ to asses dietary habits.
Active Comparator: 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.
Dietary supplement: CDED+dairy
Dietary intervention (Specific exclusion diet plus early dairy introduction). Focus on 24 hour diet recalls to asses adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feacal calprotectin
Time Frame: Baseline, 6 weeks, 12 weeks
Comparison of faecal calprotectin change between study groups.
Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response-Harvey-Bradshaw Index (HBI)
Time Frame: Baseline, 6 weeks, 12 weeks
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
Change in serum CRP
Time Frame: Baseline, 6 weeks, 12 weeks
Abnormal/higher values indicate worse outcomes.
Baseline, 6 weeks, 12 weeks
Change in serum Albumin
Time Frame: Baseline, 6 weeks, 12 weeks
Abnormal values indicate worse outcomes
Baseline, 6 weeks, 12 weeks
Bowel symptoms improvement
Time Frame: Baseline, 6 weeks, 12 weeks
Percent of patients who reported improvement in bowel symptoms, assessed by the validated IBDQ (bowel symptoms domain: 10 questions)
Baseline, 6 weeks, 12 weeks
Health Related Quality of Life (HR-QoL)
Time Frame: Baseline, 6 weeks, 12 weeks
HR-QoL defined by the self-administered Inflammatory Bowel Disease questionnaire (IBDQ) score. Higher IBDQ scores indicate better outcomes. Clinical response defined as increase ≥16 points.
Baseline, 6 weeks, 12 weeks
Patient's tolerance to the diet
Time Frame: Baseline, 6 weeks, 12 weeks
Intolerance: patient's refusal to continue diet (based on reporting and the 24 hour recalls); Adherence will be assessed based on the modified Medication Adherence Report Scale (MARS) questionnaire; The modified MARS questionnaire rates how closely patients adhere to the diet. A score of 1-5 indicates that the patient is not adherent; a score of 6-9 indicates that the patient is adherent.
Baseline, 6 weeks, 12 weeks
Weight (kg)
Time Frame: Baseline, 6 weeks, 12 weeks
Comparison of body weight between the groups.
Baseline, 6 weeks, 12 weeks
Body mass index (BMI) (kg/m^2)
Time Frame: Baseline, 6 weeks, 12 weeks
Comparison of Body Mass Index (BMI) (kg/m2) between the groups.
Baseline, 6 weeks, 12 weeks
Waist circumference (WC) (cm)
Time Frame: Baseline, 6 weeks, 12 weeks
Comparison of WC between groups.
Baseline, 6 weeks, 12 weeks
Handgrip strength (kg)
Time Frame: Baseline, 6 weeks, 12 weeks
Handgrip strength measured with handgrip strength dynamometer
Baseline, 6 weeks, 12 weeks
Fat mass (kg)
Time Frame: Baseline, 6 weeks, 12 weeks
Fat mass will be assessed by Bioelectrical Impedance Analysis (BIA)
Baseline, 6 weeks, 12 weeks
Fat free mass (FFM) (kg)
Time Frame: Baseline, 6 weeks, 12 weeks
Fat free mass will be assessed by Bioelectrical Impedance Analysis (BIA)
Baseline, 6 weeks, 12 weeks
Phase angle
Time Frame: Baseline, 6 weeks, 12 weeks
Phase angle will be assessed by Bioelectrical Impedance Analysis (BIA)
Baseline, 6 weeks, 12 weeks
Neck circumference (cm)
Time Frame: Baseline, 6 weeks, 12 weeks
Comparison of neck circumference measured with tape measure between the groups
Baseline, 6 weeks, 12 weeks
Mid arm circumference (MAC) (cm)
Time Frame: Baseline, 6 weeks, 12 weeks
Measured with tape measure to assess Mid-arm muscle circumference (MAMC) (for estimating FFM, when BIA is not feasible)
Baseline, 6 weeks, 12 weeks
Triceps Skinfold (TSF) (mm)
Time Frame: Baseline, 6 weeks, 12 weeks
Measured with a skinfold caliper to assess Mid-arm muscle circumference (MAMC) for estimating FFM, when BIA in not feasible)
Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evangelismos Hospital

Collaborators

Agricultural University of Athens

Investigators

  • Principal Investigator: Dimitrios Karayiannis, Dr., Evangelismos General Hospital of Athens
  • Study Director: Kalliopi Anna Poulia, Dr., Agricultural University of Athens
  • Study Chair: Gerasimos Mantzaris, Dr., Evangelismos General Hospital of Athens
  • Study Chair: Nikos Viazis, Dr., Evangelismos General Hospital of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 605/16-12-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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