Milkshake diet could boost Crohn's treatment in kids
NCT ID NCT07522528
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
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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
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ninewells Hospital
NOT_YET_RECRUITINGDundee, DD1 9SY, United Kingdom
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Royal Hospital For Children
RECRUITINGGlasgow, G51 4TF, United Kingdom
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Royal Hospital for Children & Young People
RECRUITINGEdinburgh, EH16 4TJ, United Kingdom
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The Royal Aberdeen Children's Hospital
NOT_YET_RECRUITINGAberdeen, AB25 2ZG, United Kingdom
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University Hospital Crosshouse
NOT_YET_RECRUITINGCrosshouse, KA2 0BE, United Kingdom
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University Hospital Wishaw
NOT_YET_RECRUITINGWishaw, ML2 0DP, United Kingdom
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