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Can a diet tame Crohn's Flare-Ups? new trial investigates

NCT ID NCT05606419

Disease control Sponsor: Evangelismos Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two diet plans for adults with active Crohn's disease. One group follows the Crohn's Disease Exclusion Diet (CDED) with a liquid meal replacement, while the other adds dairy back early. The goal is to see if these diets can reduce symptoms and inflammation. The trial is currently suspended and involves 44 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition or early dairy introduction
What this could lead to
If successful, this could offer a dietary approach to manage Crohn's disease symptoms and reduce inflammation without medication.
What could go wrong
This is a small, suspended trial with only 44 participants, so results may not apply widely. Dietary interventions can be hard to follow, and the study may not show clear benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease digestive system disorder inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Evangelismos General Hospital of Athens

    Athens, Attica, 10676, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.