Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study

NCT07522528 | Recruiting

• 2 other identifiers: BIOPIC-KIDSIRAS 353897
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief 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)

Keywords

Crohn's Disease; Partial Enteral Nutrition; Exclusive Enteral Nutrition; Biologic Therapy; Infliximab; Adalimumab; Combination Therapy; Paediatric

Outcome Measures

Primary Outcomes (1)

• Faecal Calprotectin

  The primary outcome of this study is to compare the proportion of patients who show normalisation of Faecal Calprotectin (FCAL) levels between the intervention (enteral nutrition) and control group (unrestricted diet). Normalisation of FCAL is defined as \< 100 mg/kg.

  Baseline to 10-12 weeks

Secondary Outcomes (34)

• Weight Paediatric Crohn's Disease Activity Index

  Baseline to 10-12 Weeks

• Faecal Calprotectin

  Baseline to 10-12 weeks

• Blood C-Reactive Protein

  Baseline to 10-12 weeks

• Blood Erythrocyte Sedimentation Rate

  Baseline to 10-12 weeks

• Blood Albumin

  Baseline to 10-12 weeks

Other Outcomes (4)

• Gut and oral microbiome composition

  Baseline to 10-12 weeks

• Gut and oral microbiome function

  Baseline to 10-12 weeks

• Associations between dietary intake and response to TNFα inhibitors

  Baseline to week 10-12

Study Arms (4)

Enteral Nutrition

EXPERIMENTAL

Paediatric patients allocated to the enteral nutrition study arm will be asked to replace varying amounts of their daily energy requirements with a proprietary formula (Ready-To-Drink Modulen, Nestle, or Modulen IBD, Nestle) for 6 weeks alongside standard of care treatment with infliximab or adalimumab as induction therapy.

Dietary Supplement: enteral nutrition

Unrestricted Diet

NO INTERVENTION

Paediatric patients allocated to the unrestricted diet study arm will be asked to follow their habitual, unrestricted diet for 6 weeks alongside standard of care treatment with infliximab or adalimumab as induction therapy.

Exclusive Enteral Nutrition

NO INTERVENTION

An observational cohort of paediatric patients receiving standard of care treatment with exclusive enteral nutrition as induction therapy.

Exclusive enteral nutrition alongside Infliximab or Adalimumab Induction Therapy

NO INTERVENTION

An observational cohort of paediatric patients receiving standard of care treatment with exclusive enteral nutrition alongside infliximab or adalimumab as induction therapy.

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.

Enteral Nutrition

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Clyde and Glasgow: collaborator
• NHS Lothian: collaborator
• NHS Tayside: collaborator
• NHS Grampian: collaborator
• NHS Ayrshire and Arran: collaborator
• NHS Lanarkshire: collaborator
• University of Glasgow: lead

Study Sites (6)

The Royal Aberdeen Children's Hospital

Aberdeen, AB25 2ZG, United Kingdom

NOT YET RECRUITING

University Hospital Crosshouse

Crosshouse, KA2 0BE, United Kingdom

NOT YET RECRUITING

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

NOT YET RECRUITING

Royal Hospital for Children & Young People

Edinburgh, EH16 4TJ, United Kingdom

RECRUITING

Royal Hospital For Children

Glasgow, G51 4TF, United Kingdom

RECRUITING

University Hospital Wishaw

Wishaw, ML2 0DP, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Central Study Contacts

Konstantinos Gerasimidis, Professor

CONTACT

+441419560580; Konstantinos.Gerasimidis@glasgow.ac.uk

Sophie F Morris, BSc (Hons)

CONTACT

+447887804802; s.morris.2@research.gla.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Nutrition

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 13, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (6)