Trial Details

Recruiting
Basic Information
Clinical ID c1980
Identifier ISRCTN14273559
Trial Title Mitochondrial DAMPs as mechanistic biomarkers of mucosal inflammation in paediatric Crohn's disease and ulcerative colitis
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Paediatric inflammatory bowel disease Digestive System
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 points over one year (0, 3 and 12 months). They will undergo a clinical assessment at each time point, including height, weight and a symptom questionnaire carried out by the study team or local clinical research facility team. Biological sampling will also occur at each visit, including blood and optional saliva and stool samples. If the patient is admitted to the hospital unexpectedly for a flare of their disease or surgery then a further disease assessment with biological sampling will take place. The study ends for the participant after their 12-month visit. Detailed clinical and phenotypic data 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 Primary outcomes include: Assessing the utility of mitochondrial DAMPs as prognostic and mechanistic biomarkers in inflammatory bowel disease Secondary outcomes include: Assessing oral-gut microbiome signatures
Participant Information
Sponsor Accord (United Kingdom)
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2026-12-31