None listed
Conditions
Brief summary
In a previous small single centre study of twenty four children with new diagnosis CD, we confirmed symptoms based score alone (PCDAI) was unreliable, blood test (CRP) had moderate utility and stool biomarkers (FC) had the best individual utility in predicting endoscopic mucosal healing. We also demonstrated that combination of PCDAI less than10, CRP less than 5mg/dl and FC less than 500 µgram/gm has greater accuracy identifying mucosal healing (SES-CD equal to 0-2) following standard EEN or Steroid induction therapy with specificity of 85% and positive like hood ratio 5.3. The reliability of this composite score (PCDAI less than 10, CRP less than 5mg/dl and FC less than 500 µgram/gm) in this small pilot study needs further validation in a larger prospective multicentre cohort study. To overcome limitations of this pilot study, we also want to extend this study to include; children with established CD experiencing clinical relapse, those in clinical remission with raised surrogate biomarkers (CRP more than 5mg/L and/or FC more than 250 µgram /gm of stool) and confirming mucosal healing in those with normal surrogate markers (CRP less than 5mg/L and FC less than 250 µgram /gm of stool and no symptoms. Our hypothesis is that establishing reliability of this composite index in predicting endoscopic healing in this mixed sample population will be useful both as a discriminative tool (for distinguishing active (SES-CD equal to 3) vs. inactive inflammation (SES-CD equal to 0-2) and evaluative tool (for defining treatment success).
Interventions
All children with suspected CD routinely undergo clinical, laboratory and endoscopic assessment at diagnosis. Follow up clinical and laboratory tests (both blood and faecal markers) are also part of routine clinical service delivery. Confirmation of mucosal healing with repeat endoscopy is already integrated into our clinical practice and remains the commonest indication (~35%) for colonoscopy in children attending PMH. Therefore, the only investigational intervention of our proposed study is to
All children with suspected CD routinely undergo clinical, laboratory and endoscopic assessment at diagnosis. Follow up clinical and laboratory tests (both blood and faecal markers) are also part of routine clinical service delivery. Confirmation of mucosal healing with repeat endoscopy is already integrated into our clinical practice and remains the commonest indication (~35%) for colonoscopy in children attending PMH. Therefore, the only investigational intervention of our proposed study is to ensure symptoms based score; stool and serum biomarkers are performed opportunistically within two weeks of clinically indicated endoscopy and an independent, central, blinded review of endoscopy images.
Sponsors
Princess Margaret Hospital Foundation
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
We expect to prospectively enrol 120 children with either new diagnosis or established CD (2-17 years) from two participating Children’s Hospital (Princess Margaret Hospital for children and Lady Cilento Children’s Hospital, Brisbane). Enrolled patients will be asked to provide routine blood and faecal samples for assessment of biomarkers (CRP, FC) to assess treatment response within two weeks of the scheduled colonoscopy. Endoscopic disease activity will be scored using a validated simple endoscopic score for Crohn's disease at the time of procedure and de-identified images will be evaluated by an independent, central, blinded review process.
Exclusion criteria
Children younger than 2 years (Very early onset IBD), patients with incomplete colonoscopy, inability to deliver the blood and stool sample within 2 weeks of colonoscopy and proven infectious ileocolitis (positive stool culture for salmonella/shigella etc) will be excluded from the study.
Outcome results
None listed