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

NCT05606419 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-09-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

CDED+PEN

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

DIETARY_SUPPLEMENT

CDED+dairy

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

Sponsors & Collaborators

  • Agricultural University of Athens

    collaborator OTHER

  • Evangelismos Hospital

    lead OTHER

Principal Investigators

  • Dimitrios Karayiannis, Dr. · Evangelismos General Hospital of Athens

  • Kalliopi Anna Poulia, Dr. · Agricultural University of Athens

  • Gerasimos Mantzaris, Dr. · Evangelismos General Hospital of Athens

  • Nikos Viazis, Dr. · Evangelismos General Hospital of Athens

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-10
Primary Completion
2026-07-31
Completion
2026-09-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05606419 on ClinicalTrials.gov