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Can a simple diet boost Crohn's treatment? new trial aims to find out

NCT ID NCT07344428

Disease control Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University 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 This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study tests whether adding a special diet (the Crohn's Disease Exclusion Diet) to standard biologic drugs can improve gut healing in adults with active Crohn's disease. About 185 participants in China will be randomly assigned to receive either the diet plus biologics or biologics alone. The main goal is to see if more patients achieve complete healing of the gut lining at 14 weeks with the combined approach.

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) combined with anti-TNF-α biologics (infliximab or adalimumab)
What this could lead to
If it works, this could point toward a more effective way to heal the gut lining in Crohn's disease, potentially reducing the need for surgery or stronger medications.
What could go wrong
This is a small, early-stage trial in one country, so results may not apply to everyone. The diet is strict and hard to follow, and the improvement in healing may be modest or not statistically significant.

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 185 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2028

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: * Age ≥18 years. * Diagnosis of Crohn's disease confirmed by endoscopy and histopathology, with active disease (CDAI ≥150). * Indicated for anti-TNF-α biologic therapy (infliximab or adalimumab) and naïve to these agents. * Willing and able to provide written informed consent. * Able to understand and comply with study requirements, including dietary intervention and scheduled follow-up. Exclusion Criteria: * Presence of severe complications requiring surgical intervention (e.g., intestinal obstruction, intra-abdominal abscess, intestinal fistula). * Severe cardiac, hepatic, or renal insufficiency (e.g., Child-Pugh class C, or eGFR \<30 mL/min/1.73 m²). * Active tuberculosis, active hepatitis B, HIV infection, or other severe opportunistic infections. * Current or history of malignancy, except non-melanoma skin cancer. * Pregnant or breastfeeding, or planning pregnancy during the study period. * Recent use (within 3 months) of other immunosuppressants (e.g., azathioprine, methotrexate) or high-dose corticosteroids (e.g., prednisone \>20 mg/day). * Severe food allergies, celiac disease, severe malnutrition (BMI \<18.5 kg/m²), or inability to adhere to CDED. * Concurrent participation in another clinical trial, or any condition that makes the patient unsuitable in the investigator's opinion.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn disease Crohn's disease；mucosal healing；dietary intervention

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Sixth afflicated of Sun-yat sen university

    Guangzhou, Guangdong, 510655, China

More trials for these conditions

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