Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study

ConditionCrohn's Disease (CD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-18

SponsorUniversity of Glasgow

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

90 Participants

are divided into 4 treatment groups

Group A: Enteral NutritionExperimental treatment 1 intervention

Group B: Unrestricted DietNo intervention 0 interventions

Group C: Exclusive Enteral NutritionNo intervention 0 interventions

Group D: Exclusive enteral nutrition alongside Infliximab or Adalimumab Induction TherapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 10-12 weeks

Secondary outcomes

Weight Paediatric Crohn's Disease Activity Index

Comparison of Weighted Paediatric Crohn's Disease Activity Index (wPCDAI) score (approximate range: 0-125) between the intervention (enteral nutrition) and control group (unrestricted diet). Higher wPCDAI scores indicate worse outcomes. Clinical response is defined as baseline wPCDAI decrease of ≥ 17.5, and clinical remission is defined as CDAI score \<12.5.

Time frame

Baseline to 10-12 Weeks

Faecal Calprotectin

Comparison of faecal calprotectin levels between the groups. Higher scores indicate worse outcomes.

Time frame

Baseline to 10-12 weeks

Blood C-Reactive Protein

Comparison of blood C-reactive protein levels between the groups. Abnormal values indicate worse outcomes.

Time frame

Baseline to 10-12 weeks

Blood Erythrocyte Sedimentation Rate

Comparison of blood erythrocyte sedimentation rates between the groups. Abnormal values indicate worse outcomes.

Time frame

Baseline to 10-12 weeks

Other outcomes

Gut and oral microbiome composition

Comparison of gut microbiome composition measured with 16S rRNA sequencing and shotgun metagenomics between subgroups of participants with Crohn's disease and healthy controls

Time frame

Baseline to 10-12 weeks

Gut and oral microbiome function

Comparison of gut microbiome function measured with various targeted and untargeted bacterial metabolites (e.g. LC-MS/NMR) between subgroups of participants with Crohn's disease and healthy controls

Time frame

Baseline to 10-12 weeks

Associations between dietary intake and response to TNFα inhibitors

Exploration of associations between dietary intake and response to TNFα inhibitors in a joint analysis including all Crohn's disease patients receiving receiving standard of care biologics.

Time frame

Baseline to week 10-12

Blood Immunophenotype and inflammatory cytokines

Comparison of the effects of different induction therapies on immunophenotype profiles (characterisation of immune cells) measured with flow cytometry immunophenotyping between the groups

Time frame

Baseline to week 10-12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Glasgow

Lead sponsor

NHS Greater Clyde and Glasgow

Collaborator

NHS Lothian

Collaborator

NHS Tayside

Collaborator

NHS Grampian

Collaborator

NHS Ayrshire and Arran

Collaborator

NHS Lanarkshire

Collaborator

Source ClinicalTrials.gov

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