None listed
Conditions
Brief summary
This proposal will confirm short term benefits of EEN on mucosal recovery and, on follow up, the favorable impact on clinical course. It will demonstrate utility or otherwise of phenotypic, genetic, biomarkers and faecal calprotectin to predict response. Mucosal and microbiome characteristics of patients with mucosal recovery will be compared with non responders to better understand mechanisms of efficacy of EEN with expectation of better targeted, safer, better tolerated, non-pharmacological therapies to induce mucosal healing and improve outcomes for children with Crohn’s disease.
Interventions
The diagnosis of Crohn’s disease willbe based on established clinical, endoscopic, histological and radiological criteria. Children will be given either Nutrison (1Kcal/ml, Nutricia UK) through Nasogastric tube (NGT) or Resource (Nestle) orally after dietetic consultation for total duration of 8 weeks.Prescribed volume will base on estimated caloric requirement aiming to gradully upgrade target volume in 3 to 5 days. In those electing NG tube, insertion can be performed during General Anaesthet
The diagnosis of Crohn’s disease willbe based on established clinical, endoscopic, histological and radiological criteria. Children will be given either Nutrison (1Kcal/ml, Nutricia UK) through Nasogastric tube (NGT) or Resource (Nestle) orally after dietetic consultation for total duration of 8 weeks.Prescribed volume will base on estimated caloric requirement aiming to gradully upgrade target volume in 3 to 5 days. In those electing NG tube, insertion can be performed during General Anaesthetic for the diagnostic endoscopy. Children struggling with oral EEN can be offered different flavours or changes to NG route. Clear fluids, Jelly, boiled lollies were allowed empirically and concurrently to improve palatability. A comprehensive evaluation including clinical, standard laboratory, Colonoscopy (review gut lining) and MRE (bowel wall thickness) will be undertaken at diagnosis and after treatment. Faecal samples, additional blood and small tissue biopsies will be collected on both occasions.Other therapies like steroids and early introduction of Imuran before first relapse may be used due to patient preference or clinician discretion but patients will undergo similar assessments at initial visit and 8 weeks.
Sponsors
Dr.Zubin Grover
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
Inclusion criteria
New Diagnosis of Paediatric Crohn's disease
Exclusion criteria
Exclusion criteria included previous exposure to: steroids, conventional Immunomodulators, biological agents; and inability to tolerate oral or Nasogastric (NG) tube EEN for a minimum of 6 weeks.
Outcome results
None listed