Crohn'sRecruiting

Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study

Not applicable · Testing enteral nutrition · 6 sites · University of Glasgow

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing enteral nutrition (a dietary supplement) as a possible treatment. Condition(s) listed: Crohn's Disease (CD).

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 6 to 18
Any sex
Healthy volunteers accepted

Some of the main requirements, copied from the record:

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…
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…

There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 90 participants are expected to take part.
Start date: 2026-03-27.
Main results expected around 2030-08 (estimate from the record).
6 study sites listed (2 marked recruiting) in United Kingdom.

Main thing being measured

Faecal Calprotectin (Baseline to 10-12 weeks)

In the researchers’ words

Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation. Two important treatments currently used to manage CD are special drug injections (biologics) or a liquid-only diet using specialised milkshakes.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Crohn's Disease (CD)
Lead sponsor	University of Glasgow
Collaborators	NHS Greater Clyde and Glasgow; NHS Lothian; NHS Tayside; NHS Grampian; NHS Ayrshire and Arran; NHS Lanarkshire
Enrollment	90 (estimated)
Start date	2026-03-27
Primary completion (est.)	2030-08
First posted	2026-04-13
Last updated	2026-04-13
Official title	Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study (BIOPIC-Kids): Combining Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Children With Active Crohn's Disease
ClinicalTrials.gov ID	NCT07522528

Interventions

enteral nutrition (Dietary Supplement)
Dietary intervention: a liquid food replacement intervention involving replacing varying amounts of energy requirements with a nutritionally complete liquid formula.

Full eligibility criteria (from the record)

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.

Locations (6)

Site	City	Country	Site status
The Royal Aberdeen Children's Hospital	Aberdeen	United Kingdom	Not yet recruiting
University Hospital Crosshouse	Crosshouse	United Kingdom	Not yet recruiting
Ninewells Hospital	Dundee	United Kingdom	Not yet recruiting
Royal Hospital for Children & Young People	Edinburgh	United Kingdom	Recruiting
Royal Hospital For Children	Glasgow	United Kingdom	Recruiting
University Hospital Wishaw	Wishaw	United Kingdom	Not yet recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.