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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
Sponsor:
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust

Brief Summary:
Please see description below

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Diagnostic Test: Intervention group

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 286 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IBD
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recruitment of children will be undertaken in 3 paediatric gastroenterology referral centres in the UK: Alder Hey Children's Hospital, Liverpool; Bristol Royal Hospital for Children, Bristol; and Birmingham Children's Hospital, Birmingham.
Criteria

Inclusion Criteria:

Children (age <18 years) capable of giving informed consent, or if age < 16 years or not capable of giving consent, with an acceptable individual capable of giving consent on the child's behalf

Children of either gender attending a paediatric gastroenterology referral clinic in whom IBD is suspected following initial clinical assessment

Further evaluation planned to diagnose the cause of the child's illness

Willing for demographic and clinical information to be used for the purposes of the study

Willing for part of the stool sample provided for routine clinical assessment to be used for the measurement of VOCs

Exclusion Criteria:

Treatment already received for IBD (e.g. polymeric formula feeds in children awaiting investigation)

Established diagnosis of a significant gut disorder (e.g. short bowel syndrome)

Failure to obtain informed consent from the young person or parent/guardian


Information from the National Library of Medicine

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


Contacts
Contact: Stephen Allen 0151 228 4811 Stephen.Allen@lstmed.ac.uk
Contact: Lucy Cooper 01512525570 lucy.cooper@alderhey.nhs.uk

Locations
United Kingdom
Alder Hey Children's Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust
Investigators
Study Director: Lucy Cooper Alder Hey Children's NHS Trust

Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03170622     History of Changes
Other Study ID Numbers: 223199
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alder Hey Children's NHS Foundation Trust:
children
paediatrics
faecal volitile organic compounds
diagnosis
pathogenesis

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis