Evaluation of Faecal Volatile Organic Compounds in the Diagnosis of Paediatric Inflammatory Bowel Disease (VOCs)
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|ClinicalTrials.gov Identifier: NCT03170622|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment|
|Inflammatory Bowel Diseases||Diagnostic Test: Intervention group|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||286 participants|
|Official Title:||Evaluation of Faecal Volatile Organic Compounds in the Diagnosis of Paediatric Inflammatory Bowel Disease|
|Actual Study Start Date :||September 29, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||September 2019|
Children (age <18 years) attending clinics in 3 paediatric gastroenterology referral centres in the UK in whom clinical assessment indicates that IBD is a possibility
Diagnostic Test: Intervention group
This group will provide a stool sample that will be analysed for VOCs and followed up after 3 months
- VOCs [ Time Frame: Visit 1-1day ]
For the VOCS identified by GCMS, consistent with our findings in adults (Ahmed 2016), we anticipate identifying a small number of VOCs that can be used to diagnose IBD and distinguish IBD from other common pathologies including functional abdominal conditions.
For the results generated by the GC-sensor (Odoreader©), we will compare the faecal VOC profile in children in whom IBD is confirmed with that in children with alternative diagnoses according to the advanced statistical methods required for determining and comparing VOC profiles.
- Underlying disease [ Time Frame: Visit 1-1 day ]Similar analyses as for the primary outcome will be used for the secondary outcomes. To shed light on underlying disease mechanisms in pIBD and other common conditionse will use existing KEGG databases to determine the source of faecal VOCs identified by GCMS, which will include bacteria, fungi, host tissues and metabolism (http://www.genome.jp/kegg/kegg2.html).
- Sub-group analysis [ Time Frame: Visit 1-1 day ]We will fully explore the data from our non-IBD children to identify characteristic faecal VOC profiles in common diagnostic groups (e.g. functional abdominal pain, coeliac disease) and also demographic and environmental factors (e.g. age, sex, diet) using the approaches described above.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170622
|Contact: Stephen Allen||0151 228 4811||Stephen.Allen@lstmed.ac.uk|
|Contact: Lucy Cooperfirstname.lastname@example.org|
|Alder Hey Children's Hospital||Recruiting|
|Liverpool, Merseyside, United Kingdom, L12 2AP|
|Study Director:||Lucy Cooper||Alder Hey Children's NHS Trust|