CClinicalTrials.gg
CompletedNCT06448819Updated Jun 7, 2024

Real-life Use of the Crohn's Disease Exclusion Diet (CDED) in Adult Patients With Crohn's Disease

An interventional study of Diet in Crohn Disease, sponsored by Universita degli Studi di Genova. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by Universita degli Studi di Genova · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study explores the effectiveness od the Crohn's Disease Exclusion Diet (CDED) as a tretament for adults with mild-to-moderate Crohn's disease (CD). The hypotesis is that CDED, by excluding specific dietary components thought to exacerbate gut inflammation, can induce remission in CD patients more effectively than a control diet based on the Mediterranean pattern. Conducted as an open-label randomized trial, the research aim to provide real-world evidence of CDED's safety and its inpact on clinical remission, body composition and overall quality of life for CD patients.

02

Conditions studied

  • Crohn Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 461 are open to participants now.

This study's enrollment of 45 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Universita degli Studi di Genova is the lead sponsor of 21 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mild-to-moderate Crohn's disease activity (HBI between 5 and 16)

Exclusion criteria

Exclusion Criteria:

  • concomitant treatment with corticosteroids, antibiotic therapies and nutraceutical supplements, treatment with biological drugs and traditional immunosuppressants started less than 24 weeks before enrollment, presence of active fistulas or abscesses, gastrointestinal tract surgery less than 6 months to randomization, coeliac disease, type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, acute coronary disease (unstable angina, myocardial infarction), advanced acute or chronic liver disease, congestive heart failure (NYHA class III-IV), acute and chronic nephropathies (GRF\<30 ml/min according to the CKD-EPI formula), presence of acute infectious diseases and pregnancy.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    CDED group

    Crohn's disease exclusion diet Partecipants received Crohn's disease exclusion diet or Mediterranean diet for 24 weeks

    Other: Diet

  • No intervention
    Mediterranean group

Interventions

  • OtherDiet

    Patients received Crohn's disease exclusion diet or Mediterranean diet

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What researchers measure

Primary outcomes

  1. Harvey-Bradshaw Index (HBI

    Time frame: 12 weeks; 24 weeks

Secondary outcomes

  1. Fecal calprotectin

    Time frame: 12 weeks; 24 weeks

07

Study locations

1 site
  • Giorgia Bodini
    Genova, 16132, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06448819
Lead sponsor
Universita degli Studi di Genova
Responsible party
Giorgia Bodini (Prof, Universita degli Studi di Genova) — Principal investigator
First posted
Jun 7, 2024
Start date
Jan 20, 2023
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Jun 7, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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