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Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study

NCT07522528 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-13

No results posted yet for this study

Summary

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. However, treatment with biologics is only successful in approximately 55-60%. The liquid-only diet also has a better safety and effectiveness profile than traditional treatments like steroids. However, gut inflammation often returns not long after the normal diet is re-introduced, and it is difficult for patients to stick to as their sole source of nutrition for 6-8 weeks.

The BIOPIC-Kids study aims to investigate whether replacing the normal diet with specialised milkshakes for 6 weeks improves response to treatment and maintenance of remission with biologics in children and young adults with CD. To achieve this, children and young adults (aged 6-18 years) with active CD commencing biologics as standard of care treatment will be randomly allocated to follow their normal diet OR replace varying amounts of their normal diet with specialised milkshakes for 6 weeks. Participants not wanting to be randomised can choose the group of their preference. Patients starting a liquid-only diet OR biologics alongside a liquid-only diet as standard of care treatment will also be recruited to compare different treatment outcomes.

Conditions

  • Crohn's Disease (CD)

Interventions

DIETARY_SUPPLEMENT

enteral nutrition

Dietary intervention: a liquid food replacement intervention involving replacing varying amounts of energy requirements with a nutritionally complete liquid formula.

Sponsors & Collaborators

  • NHS Greater Clyde and Glasgow

    collaborator OTHER

  • NHS Lothian

    collaborator OTHER_GOV

  • NHS Tayside

    collaborator OTHER_GOV

  • NHS Grampian

    collaborator OTHER_GOV

  • NHS Ayrshire and Arran

    collaborator OTHER

  • NHS Lanarkshire

    collaborator OTHER_GOV

  • University of Glasgow

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2030-08-31
Completion
2030-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07522528 on ClinicalTrials.gov