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Liquid diet shows promise for Crohn's patients in new study

NCT ID NCT07504510

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Updated 2 times

Summary

This study looks at whether a special liquid diet called exclusive enteral nutrition (EEN) can help adults with active Crohn's disease feel better and reduce inflammation. About 300 participants will use EEN as their main treatment for 12 weeks. Researchers will check remission rates, symptoms, and safety, especially in patients with complications like strictures or abscesses.

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.

Participants

About 300 people

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

Started

Jun 2020

Expected to finish

Dec 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.

Who is studied

Adult patients (≥18 years) with active Crohn's disease treated at a single center who initiate exclusive enteral nutrition (EEN) as the sole induction therapy and are followed for 12 weeks. The study population primarily includes patients with malnutrition or nutritional risk, and many have complicated disease with intestinal fistula, stricture, and/or intra-abdominal abscess.

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: 1. Age ≥18 years. 2. Diagnosis of Crohn's disease established on the basis of overall clinical assessment, including compatible clinical history and standard endoscopic, histologic, and/or radiologic findings, as determined by the treating physician. Histologic confirmation at baseline is not required if endoscopy or biopsy is not feasible or clinically inappropriate because of severe disease, poor nutritional status, or intra-abdominal abscess/sepsis. 3. Active Crohn's disease at baseline, as determined by the treating physician. 4. Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care. 5. Presence of malnutrition or nutritional risk and clinical indication for EEN. 6. Patients with intestinal complications, including enteric fistula, intestinal stricture, and/or intra-abdominal abscess, are eligible if considered appropriate for EEN-based management by the treating physician. 7. Ability and willingness to provide written informed consent and to comply with study assessments and follow-up for 12 weeks. Optional clarifying note: In participants without histologic confirmation at baseline, the diagnosis may be further confirmed during follow-up when clinically feasible, including by endoscopic biopsy or surgical pathology. Exclusion Criteria 1. Any absolute contraindication to enteral nutrition, including but not limited to gastrointestinal perforation, uncontrolled gastrointestinal bleeding, severe hemodynamic instability/shock, or other conditions where enteral feeding is not clinically appropriate. 2. Immediate need for emergency surgery at baseline. 3. Inability or unwillingness to receive EEN as the sole induction therapy at baseline. 4. Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.

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Conditions

The condition(s) this trial relates to.

Abdominal Abscess Crohn disease

As listed by the trial registrant

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

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

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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