Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Milkshake diet could boost Crohn's treatment in kids

NCT ID NCT07522528

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at whether replacing a normal diet with specialized milkshakes for 6 weeks can improve how well biologic drugs work in children aged 6-18 with active Crohn's disease. About 90 participants will either follow their normal diet or drink the milkshakes alongside their biologic treatment. The goal is to see if the combination reduces gut inflammation better than biologics alone.

What this could mean

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

Active substance
enteral nutrition (specialized liquid milkshakes)
What this could lead to
If it works, this could show that combining a liquid diet with biologics improves treatment response and helps children with Crohn's stay in remission longer.
What could go wrong
This is a small, early-stage study (90 participants) and the liquid diet is hard to stick to. It may not significantly improve outcomes, and results may not apply to all patients.

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 90 people

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

Started

Mar 2026

Expected to finish

Aug 2030

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

6 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Eligible participants to the RCT are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \>250 mg/kg and who have a clinical indication to initiate standard of care induction treatment with TNFα inhibitors (infliximab or adalimumab). * Eligible participants to the observational cohorts are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \>250 mg/kg and who are due to initiate standard of care induction treatment with EEN therapy alongside TNFα inhibitors (infliximab or adalimumab) or standard of care induction treatment with EEN therapy without TNFα inhibitors (infliximab or adalimumab) Exclusion Criteria: * Inability to provide consent to participate in the study (i.e., this applies to young adults (aged 16-18 years) who are old enough but unable to provide consent and carers (of children aged 6-15 years old) who are unable to provide consent on behalf of their child). * Presence of stoma or of short bowel syndrome. * Patients currently receiving oral or intravenous steroids at a dosage \>20mg/day prednisolone or \>9mg/day budesonide. * Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks. * CD with a major fistulising or symptomatic fibrotic stricturing phenotype. * Patients with comorbid anorexia nervosa. * Any clinical contraindication to use of exclusive enteral nutrition or partial enteral nutrition. * Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C. * Patients with untreated tuberculosis (latent or active). * Current enrolment in other studies of an investigational product or dietary intervention. * Food allergies, which do not permit participation in the study (e.g., cow's milk allergy). * Pregnant and/or breastfeeding individuals.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Crohn's disease (CD) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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

    6 sites. 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

  • Ninewells Hospital

    NOT_YET_RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Royal Hospital For Children

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Royal Hospital for Children & Young People

    RECRUITING

    Edinburgh, EH16 4TJ, United Kingdom

  • The Royal Aberdeen Children's Hospital

    NOT_YET_RECRUITING

    Aberdeen, AB25 2ZG, United Kingdom

  • University Hospital Crosshouse

    NOT_YET_RECRUITING

    Crosshouse, KA2 0BE, United Kingdom

  • University Hospital Wishaw

    NOT_YET_RECRUITING

    Wishaw, ML2 0DP, United Kingdom

More trials for these conditions

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