Faecal volatiles in children with inflammatory bowel disease

Plain English Summary

Background and study aims
Inflammatory bowel disease (IBD) is a term used to describe conditions which cause long-term inflammation (swelling) in the gut. The two main forms of IBD are Crohn’s disease (CD) and ulcerative colitis (UC). Crohn’s disease can affect any part of the gut, but is most commonly at the end of the ileum (the last part of the small intestine) or the colon (the large intestine). Ulcerative colitis generally affects the colon and rectum (the last part of the large intestine). It has become much more common in children in recent years such that 1 in 4 of all new cases now occur in young people. Gastrointestinal endoscopy (a test where a flexible tube with a camera on the end is through the mouth into the gut) and imaging are required to confirm a diagnosis in children with suspected IBD. These investigations can be distressing for some children and their families, can delay diagnosis and the start of treatment and are costly to the NHS. They also often need repeating at regular intervals further impairing quality of life. Children and families voice a strong desire for tests that are non-invasive and give a rapid result. The measurement of a marker called “calprotectin” in a stool sample is very helpful in detecting intestinal inflammation. However, it does not distinguish IBD from other causes of intestinal inflammation such as gut infections. Various human tissues, including stool, give off vapours that contain volatile organic compounds (VOCs) that give them their characteristic smell. VOCs are produced by the cells lining the intestine and the microorganisms in the gut and can be measured quickly in the clinic at low cost. The type and quantity of VOCs change when the intestine is affected by a disease. It has been shown that the VOCs in adults with IBS were different from those with IBD. Also, VOCs were different in adults with inflammation of the large bowel due to Crohn’s disease than due to ulcerative colitis. The aim of this study is to see whether stool VOCs can replace other investigations for IBD such as endoscopy and imaging in children.

Who can participate?
Children who have suspected IPD who have been referred to gastroenterology clinics for investigation.

What does the study involve?
Information about age, symptoms and factors that could change children’s gut bacteria such as recent treatment with antibiotics is collected before children are assessed investigated by their usual doctors in the usual way. Three months later, medical records are reviewed to find out what diagnosis was made. Stool VOCs that were present when they first came to hospital in those who turn-out to have IBD with those who have other gastrointestinal problems are then compared. In children who turn-out to have IBD, the researchers also see if the stool VOCs differed according to the type of disease (Crohn’s disease versus ulcerative colitis), how severe the inflammation was and the part of the intestine affected. Finally, measure stool VOCs are measured again at three months in children with IBD to see if it a useful way of assessing their response to treatment.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for participants.

Where is the study run from?
1. Alder Hey Children’s Hosptial (UK)
2. Bristol Royal Hospital for Children (UK)
3. Birmingham Children's Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2017 to April 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Stephen Allen
Stephen.allen@lstmed.ac.uk

Contact information

Prof Stephen Allen
Public

Room M-215 Department of Clinical Sciences
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

ORCID ID	0000-0001-6675-249X
Phone	+44 151 705 3752
Email	stephen.allen@lstmed.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

Alder Hey Children’s NHS Foundation Trust
Hospital/treatment centre

Eaton Road
Liverpool
L12 2AP
England
United Kingdom

Phone	+44 151 228 4754
Email	Charlie.Orton@alderhey.nhs.uk
Website	http://www.alderhey.nhs.uk/
"ROR"	https://ror.org/00p18zw56

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN11314352_PROTOCOL_V2.0_11Oct17.pdf

Editorial Notes

18/08/2023: The intention to publish date has been changed from 15/08/2023 to 15/02/2024.
05/04/2023: The intention to publish date was changed from 07/04/2023 to 15/08/2023.
17/03/2023: The intention to publish date has been changed from 30/09/2022 to 07/04/2023.
28/09/2022: Uploaded protocol (not peer reviewed).
28/03/2022: The intention to publish date was changed from 31/03/2022 to 30/09/2022.
31/12/2021: The following changes have been made:
1. The ethics approval has been added.
2. The intention to publish date has been changed from 30/06/2021 to 31/03/2022.
10/06/2021: The total final enrolment number has been changed from 432 to 264.
09/06/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/10/2017 to 27/06/2017.
2. The recruitment end date has been changed from 30/09/2019 to 30/06/2020.
3. The overall trial end date has been changed from 01/04/2017 to 27/06/2017 and the plain English summary has been updated to reflect this change.
4. The total final enrolment number has been added.
11/02/2019: The following changes were made:
1. The recruitment end date was changed from 31/12/2018 to 30/09/2019
2. The overall trial end date was changed from 30/04/2019 to 30/06/2020
3. The intention to publish date was changed from 31/12/2019 to 30/06/2021