Biologics plus a 6-week enteral nutrition plan for children with Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will recruit about 90 children and young adults with active Crohn's disease who are starting TNFα inhibitor therapy (infliximab or adalimumab) at six centres across Scotland. Participants will be randomised or allocated by choice to follow either their usual unrestricted diet or an enteral nutrition regimen that replaces varying amounts of their diet for the first 6 weeks of biologic induction. The investigators will compare clinical remission and biomarker normalization after 10–12 weeks and track how many participants remain symptom-free for up to one year. Secondary measures include nutrition and body composition, quality of life, immune profiling, inflammatory cytokines, and gut and oral microbiome composition and function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Royal Hospital for Children & Young People
  Edinburgh, United Kingdom Recruiting
• Royal Hospital For Children
  Glasgow, United Kingdom Recruiting
• 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
• University Hospital Wishaw
  Wishaw, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Konstantinos Gerasimidis, Professor
• Email: Konstantinos.Gerasimidis@glasgow.ac.uk
• Phone: +441419560580

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ultrasound-guided margin choice during ileocolic resection for Crohn's disease

  This trial tests whether using ultrasound to guide how much tissue to remove during ileocolic surgery for terminal ileal Crohn's disease helps people see better outcomes than using the usual surgeon-determined margins.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07680283

• Tailored Anti-Inflammatory Diet for Crohn's Disease

  This study tests a personalized anti-inflammatory diet for people with Crohn’s disease to see if it improves symptoms and inflammation and to find biomarkers of response.

  Recruiting University of Miami · Miami, Florida · NCT07671872

• Ketogenic versus Carnivore (Lion) diets for inflammatory bowel disease and rheumatoid arthritis

  This trial will test whether a ketogenic diet or a carnivore (lion) diet can reduce symptoms, improve quality of life, and lower inflammation in adults with IBD or rheumatoid arthritis.

  Recruiting Fuller Research Foundation · Charlottesville, Virginia · NCT07524244

• Over-the-counter pain medicine comparison for period cramps in women with Crohn's disease

  This pilot will test whether ibuprofen or acetaminophen relieves period cramps more effectively and safely for women aged 18–44 who have Crohn's disease in remission.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT07337902

• Zymfentra (infliximab-dyyb) real-world cohort

  This project will see if Zymfentra (infliximab-dyyb) reduces symptoms over one year in adults with Crohn's disease, ulcerative colitis, or indeterminate colitis who are starting or switching to the drug as part of routine care.

  Recruiting at 11 sites University of North Carolina, Chapel Hill · New Haven, Connecticut and 10 other locations · NCT07237516

• BCD-261 (anti‑TL1A) treatment for adults with moderate to severe Crohn's disease testing several dose regimens

  This trial will test whether different doses of the anti‑TL1A antibody BCD-261 help adults with moderate to severe Crohn's disease who have not responded to steroids, immunosuppressants, or biologics.

  Recruiting at 20 sites Phase 2 Biocad · Barnaul, Altayskiy Kray and 19 other locations · NCT07078994

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.