Crohn's Disease (CD)BIOPIC-KidsNCT07522528
Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study
A study testing enteral nutrition in people with Crohn's Disease (CD), run by University of Glasgow at 6 sites in United Kingdom.
Trial 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%. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease (CD)
- What is being tested?
- enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 27 Mar 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
The Royal Aberdeen Children's Hospital
Aberdeen, AB25 2ZG
Iain S Chalmers, MBChB, iain.chalmers@nhs.scot
- Not yet recruiting
University Hospital Crosshouse
Crosshouse, KA2 0BE
Lawrence Armstrong, MBCHB, MRCPCH, Lawrence.Armstrong@aapct.scot.nhs.uk
- Not yet recruiting
Ninewells Hospital
Dundee, DD1 9SY
Richard Hansen, MBChB, PhD, FRCPCH, FRCP Edin, richard.hansen2@nhs.scot
- Recruiting
Royal Hospital for Children & Young People
Edinburgh, EH16 4TJ
Richard K Russell, MBChB, MRCP, MRCPCH, PhD, Richard.Russell@nhs.scot
- Recruiting
Royal Hospital For Children
Glasgow, G51 4TF
Lisa Gervais, MSc, Lisa.Gervais2@nhs.scot
- Not yet recruiting
University Hospital Wishaw
Wishaw, ML2 0DP
Thomas J Jordan, MBBS, BSc, Thomas.Jordan@lanarkshire.scot.nhs.uk
About this study
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
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.
Read the detailed description
90 Paediatric patients with active Crohn's disease (CD) who are due to start standard of care treatment with TNF alpha (TNFα) inhibitors infliximab(IFX) or adalimumab(ADA) will be recruited from six centres across Scotland for this study. Participants will be randomised, or allocated by their choice, to either follow their unrestricted diet or a liquid diet (enteral nutrition) that replaces varying amounts of their unrestricted diet for the first 6 weeks of IFX/ADA induction therapy. Observational cohorts receiving standard of care treatment with exclusive enteral nutrition (EEN therapy) or IFX/ADA alongside adjuvant EEN therapy will be recruited to compare the outcomes of different treatments.
The investigators will compare the proportion of patients whose symptoms and disease markers will improve between the groups following 10-12 weeks of induction therapy, and how many of them will remain symptoms-free for up to a year following treatment. The study will also explore whether the study's liquid diet will influence patient's nutrition, body composition and quality of life. Additionally, host immunophenotype, inflammatory cytokines and the gut and oral microbiome, including composition and function will be explored.
The primary aim of this study is to investigate if replacement of the habitual diet with varying amounts of enteral nutrition for 6 weeks in total, will improve rates of clinical remission and normalisation of biomarkers of mucosal healing in children and young adults with active CD receiving biologic therapy with TNFα inhibitors compared to children with active CD receiving biologic therapy and consuming their habitual, unrestricted diet. The secondary aim of this study is to investigate if the nutritional regime above will reduce risk of secondary loss of treatment response, and of subsequent disease relapse.
- Conditions
- Crohn's Disease (CD)
- Being tested
- enteral nutrition
- Keywords
- Crohn's Disease, Partial Enteral Nutrition, Exclusive Enteral Nutrition, Biologic Therapy, Infliximab, Adalimumab, Combination Therapy, Paediatric
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionDietary supplement
Dietary intervention: a liquid food replacement intervention involving replacing varying amounts of energy requirements with a nutritionally complete liquid formula.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 10-12 weeks
Secondary outcomes (34)
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.
Measured: Baseline to 10-12 Weeks
Faecal Calprotectin
Comparison of faecal calprotectin levels between the groups.
Higher scores indicate worse outcomes.
Measured: Baseline to 10-12 weeks
Blood C-Reactive Protein
Comparison of blood C-reactive protein levels between the groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 10-12 weeks
Blood Erythrocyte Sedimentation Rate
Comparison of blood erythrocyte sedimentation rates between the groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 10-12 weeks
Blood Albumin
Comparison of blood albumin levels between the groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 10-12 weeks
Blood Haemoglobin
Comparison of blood haemoglobin levels between the two groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to weeks 10-12
Steroid-Free Remission
Comparison of steroid-free remission rates between the groups
Measured: Baseline to 52 weeks (+/-2 weeks)
Dosage of biologics
Comparison of cumulative dosage of biologics required to enter in clinical remission and maintain therapeutic drug levels between the groups treated with biologics as standard of care treatment.
Measured: Baseline to 52 weeks (+/- 2 weeks)
Blood anti-drug antibodies
Comparison of blood anti-drug antibodies between the groups of patients on standard of care biologic therapy.
Measured: Week 6 to 52 weeks (+/- 2 weeks)
Blood Infliximab or Adalimumab
Comparison of trough levels of infliximab or adalimumab (drug) in blood between the groups receiving standard of care treatment with biologics
Measured: Week 6 to 52 weeks (+/- 2 weeks)
Health-related quality of life
Comparison of health-related quality of life (using the IMPACT-III questionnaire) between the groups (minimum score: 35, maximum: 175). Higher scores indicate better quality of life.
Measured: Baseline to 10-12 Weeks
Body Mass Index (BMI)
Comparison of Body Mass Index (BMI) (kg/m2) between the groups
Measured: Baseline to 10-12 weeks
Body Weight
Comparison of body weight (kg) between the groups
Measured: Baseline to 10-12 weeks
Body Composition (Total Body water, Body Fat Mass, Body Fat Free Mass)
Comparison of total body water (percent, %), body fat mass (percent, %) and body fat-free mass (percent, %) with bioelectrical impedance analysis and the deuterium oxide dilution method.
Measured: Baseline to 10-12 weeks
Paediatric Yorkhill Malnutrition Score (PYMS)
Comparison of Paediatric Yorkhill Malnutrition Score (PYMS) between the groups. Minimum score: 0; maximum score: 7. Scores of 0 indicate low risk of malnutrition, scores of 1 indicate a medium risk of malnutrition and scores of 2 or above indicates a high risk of malnutrition.
Measured: Baseline to 10-12 weeks
Handgrip strength
Comparison of handgrip strength measured with handgrip strength dynamometer between the groups
Measured: Baseline to 10-12 weeks
Micronutrient blood levels (vitamin A)
Comparison of blood vitamin A levels (µmol/L) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B1)
Comparison of blood Vitamin B1 levels (ng/g Hb) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B2)
Comparison of blood Vitamin B2 levels (nmol/g Hb) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B6)
Comparison of blood Vitamin B6 levels (pmol/g Hb) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B12)
Comparison of blood vitamin B12 levels (pmol/L) between groups.
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin C)
Comparison of blood Vitamin C levels (umol/L) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin D)
Comparison of blood Vitamin D levels (mmol/L) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin E)
Comparison of blood Vitamin E levels (µmol/mmol of cholesterol) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin K)
Comparison of blood Vitamin K levels (nmol/mmol triglyceride) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Folate)
Comparison of blood folate levels (ug/L) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (zinc)
Comparison of blood zinc levels (µmol/L) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Magnesium)
Comparison of blood magnesium levels (mmol/L) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient Blood Levels (Copper)
Comparison of blood copper levels (µmol/L between the groups
Measured: Baseline to 10-12 weeks
Micronutrient blood levels (Selenium)
Comparison of blood selenium levels (µmol/L) between the groups
Measured: Baseline to 10-12 weeks
Micronutrient blood levels (Ferritin)
Comparison of blood ferritin levels (µg/L) between the groups
Measured: Baseline to 10-12 weeks
Dietary Habits
Comparison of dietary habits between patients with Crohn's disease and healthy controls (using a child appropriate food frequency questionnaire (FFQ)
Measured: Baseline
Acceptability of EN feeds Questionnaires
Comparison of acceptability of EN feeds between groups of participants receiving either the study's liquid diet or standard of care EEN using acceptability questionnaires developed by the research team as non-validated tools designed to gauge participants' acceptability and opinion of the EN feeds. These consist of a series of 9-point hedonic scales representing the degree to which participants like or dislike different sensory attributes of the EN feeds (e.g., taste, smell etc.,). Approximate score range: 5 - 45. Higher scores indicate a higher preference for the EN feed. An additional section included asks participants to rank their overall preference of the EN feeds from 1 to 4 (1= the product liked best and 4= the product liked the least). A lower ranking indicates the EN feed liked best.
Measured: Baseline to week 6 or completion of standard of care EEN
Adherence to EN feeds Questionnaires
Comparison of adherence to EN between groups of participants receiving either the study's liquid diet or standard of care EEN using adherence questionnaires developed by the research team as non-validated tools designed to assess participants' adherence to their liquid diet. The questionnaires consist of yes/no questions or 5-point scales representing the degree to which participants did adhere or did not adhere to different aspects of their liquid diet (1: Always (>95% of the time); 2: Often (80% of the time); 3: Half of the time (50% of the time); 4: Rarely (20% of the time) and 5: Never (<5% of time)). A score of 42 indicates highest adherence and a score of 18 indicates lowest adherence.
Measured: Baseline to week 6 or completion of standard of care EEN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start27 Mar 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Clyde and Glasgow, NHS Lothian, NHS Tayside, NHS Grampian, NHS Ayrshire and Arran, NHS Lanarkshire
- Responsible party
- Principal investigator, Dr Konstantinos Gerasimidis, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522528
- Sponsor's protocol ID
- BIOPIC-KIDS
- Other IDs
- IRAS 353897
- Acronym
- BIOPIC-Kids
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be asked to provide written consent for their anonymised data to be made available to public repositories.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- BIOPIC-Kids / BIOPIC-KIDS
- Conditions
- Crohn's Disease (CD)
- Keywords
- Crohn's Disease, Partial Enteral Nutrition, Exclusive Enteral Nutrition, Biologic Therapy, Infliximab, Adalimumab, Combination Therapy, Paediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Clyde and Glasgow, NHS Lothian, NHS Tayside, NHS Grampian, NHS Ayrshire and Arran, NHS Lanarkshire
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
90 Paediatric patients with active Crohn's disease (CD) who are due to start standard of care treatment with TNF alpha (TNFα) inhibitors infliximab(IFX) or adalimumab(ADA) will be recruited from six centres across Scotland for this study. Participants will be randomised, or allocated by their choice, to either follow their unrestricted diet or a liquid diet (enteral nutrition) that replaces varying amounts of their unrestricted diet for the first 6 weeks of IFX/ADA induction therapy. Observational cohorts receiving standard of care treatment with exclusive enteral nutrition (EEN therapy) or IFX/ADA alongside adjuvant EEN therapy will be recruited to compare the outcomes of different treatments.
The investigators will compare the proportion of patients whose symptoms and disease markers will improve between the groups following 10-12 weeks of induction therapy, and how many of them will remain symptoms-free for up to a year following treatment. The study will also explore whether the study's liquid diet will influence patient's nutrition, body composition and quality of life. Additionally, host immunophenotype, inflammatory cytokines and the gut and oral microbiome, including composition and function will be explored.
The primary aim of this study is to investigate if replacement of the habitual diet with varying amounts of enteral nutrition for 6 weeks in total, will improve rates of clinical remission and normalisation of biomarkers of mucosal healing in children and young adults with active CD receiving biologic therapy with TNFα inhibitors compared to children with active CD receiving biologic therapy and consuming their habitual, unrestricted diet. The secondary aim of this study is to investigate if the nutritional regime above will reduce risk of secondary loss of treatment response, and of subsequent disease relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition | Experimental | Dietary Supplement: enteral nutritionPaediatric 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. |
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutritionDietary intervention: a liquid food replacement intervention involving replacing varying amounts of energy requirements with a nutritionally complete liquid formula. | Dietary supplement | Enteral Nutrition |
Primary outcome
Faecal Calprotectin
Time frame: Baseline to 10-12 weeks
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.
34 secondary outcomes
Weight Paediatric Crohn's Disease Activity Index
Time frame: Baseline to 10-12 Weeks
Faecal Calprotectin
Time frame: Baseline to 10-12 weeks
Blood C-Reactive Protein
Time frame: Baseline to 10-12 weeks
Blood Erythrocyte Sedimentation Rate
Time frame: Baseline to 10-12 weeks
Blood Albumin
Time frame: Baseline to 10-12 weeks
Blood Haemoglobin
Time frame: Baseline to weeks 10-12
Steroid-Free Remission
Time frame: Baseline to 52 weeks (+/-2 weeks)
Dosage of biologics
Time frame: Baseline to 52 weeks (+/- 2 weeks)
Blood anti-drug antibodies
Time frame: Week 6 to 52 weeks (+/- 2 weeks)
Blood Infliximab or Adalimumab
Time frame: Week 6 to 52 weeks (+/- 2 weeks)
Health-related quality of life
Time frame: Baseline to 10-12 Weeks
Body Mass Index (BMI)
Time frame: Baseline to 10-12 weeks
Body Weight
Time frame: Baseline to 10-12 weeks
Body Composition (Total Body water, Body Fat Mass, Body Fat Free Mass)
Time frame: Baseline to 10-12 weeks
Paediatric Yorkhill Malnutrition Score (PYMS)
Time frame: Baseline to 10-12 weeks
Handgrip strength
Time frame: Baseline to 10-12 weeks
Micronutrient blood levels (vitamin A)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B1)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B2)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B6)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin B12)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin C)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin D)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin E)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Vitamin K)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Folate)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (zinc)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Magnesium)
Time frame: Baseline to 10-12 weeks
Micronutrient Blood Levels (Copper)
Time frame: Baseline to 10-12 weeks
Micronutrient blood levels (Selenium)
Time frame: Baseline to 10-12 weeks
Micronutrient blood levels (Ferritin)
Time frame: Baseline to 10-12 weeks
Dietary Habits
Time frame: Baseline
Acceptability of EN feeds Questionnaires
Time frame: Baseline to week 6 or completion of standard of care EEN
Adherence to EN feeds Questionnaires
Time frame: Baseline to week 6 or completion of standard of care EEN
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Participants will be asked to provide written consent for their anonymised data to be made available to public repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition in people with Crohn's Disease (CD), run by University of Glasgow at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Gerasimidis, Professor (+441419560580, Konstantinos.Gerasimidis@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal Calprotectin (time frame: Baseline to 10-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.