Evaluation of Faecal Volatile Organic Compounds in the Diagnosis of Paediatric Inflammatory Bowel Disease

NCT03170622 | Completed

• 1 other identifier: 223199
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Please see description below

Conditions

Inflammatory Bowel Diseases

Keywords

children; paediatrics; faecal volitile organic compounds; diagnosis; pathogenesis

Outcome Measures

Primary Outcomes (1)

• VOCs

  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.

  Visit 1-1day

Secondary Outcomes (1)

• Underlying disease

  Visit 1-1 day

Other Outcomes (1)

• Sub-group analysis

  Visit 1-1 day

Study Arms (1)

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

Interventions

Intervention group DIAGNOSTIC_TEST

This group will provide a stool sample that will be analysed for VOCs and followed up after 3 months

IBD

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucy Cooper

  Alder Hey Children's NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 31, 2017
• Study Start: October 2, 2017
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)