Paediatric inflammatory bowel disease Digestive System
Conditions
Interventions
This is a multi-centre longitudinal observational cohort study following paediatric inflammatory bowel disease patients, aged 6-17 years, with clinical assessment and biological sampling at three-time
saliva for microbiome analysis
stool for microbiome analysis
and gut biopsies for transcriptomics and microbiome analysis
Primary outcomes include:
Assessing the utility of mitochondrial DAMPs as prognostic and mechanistic biomarkers in inflammatory bowel dise
Sponsors
Accord (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 6 - 17 years old 2. A diagnosis of IBD (CD, UC or IBD-U) 3. All patients must have active IBD at the time of screening: Active IBD symptoms by referring clinician’s judgement in addition to one of the following criteria (within 6 weeks of screening): FC level of >100ug/g; Blood CRP >5mg/l; Endoscopic, radiological or histological evidence of active IBD 4. All new diagnosis PIBD patients will require a recent ileo-colonoscopy within 6 weeks of recruitment that has: 4.1. Clear documentation of endoscopic disease activity and extent (SES-CD for CD; Mayo Score for UC) 4.2. Photographs of endoscopic mucosal IBD disease activity 5. If patients have undergone an ileo-colonoscopy within 6 weeks but with an endoscopic report that is insufficient in endoscopic disease activity data as per (4), potential participants can still be considered providing there is: 5.1. Supporting objective evidence of IBD disease activity (FC, CRP) within 2 weeks of index endoscopic assessment 6. Patients who have evidence of an active IBD flare (as per 3) or are changing IBD therapies due to treatment failure can be included in the study without a recent ileo-colonoscopy if the referring clinician considers omitting it as their local standard of care.
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each of the following primary outcome measures will be assessed at 0, 3 and 12 months plus any additional admissions to the hospital: 1. Full blood count (FBC), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels measured using blood tests 2. Biological sampling including blood (cfDNA, RNA, plasma, standard disease biomarkers - CRP/ESR/FBC); saliva for microbiome analysis; stool for microbiome analysis; and gut biopsies for transcriptomics and microbiome analysis Disease course and severity will be recorded using the study's case report forms Height will be measured using a tape measure Weight will be measured using scales Blood will be taken by venepuncture by the research team Saliva will be collected in a specialised tube by the patient and given to the research team Stool samples will be collected in a specialised tube by the patient and given to the research team | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral-gut microbiome signatures measured using saliva and stool collected in specialised tubes by the patient and given to the research team at 0, 3 and 12 months plus during any additional admissions to the hospital | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactDavid Wands
Outcome results
None listed