Home-Based Stool Testing in IBD (HOST-IBD)
Research type
Research Study
Full title
Early measurement of faecal calprotectin as a predictor of primary non-response to treatment in paediatric Crohn’s disease: a pilot study
IRAS ID
220856
Contact name
Astor Rodrigues
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Testing stool for markers of inflammation has boosted our ability to diagnose inflammatory bowel disease (IBD) early in children. While effective treatments exist, some children need to try several different types before they find one that works for them. This has an adverse effect on their quality of life, and risks the development of complications. A simple test that could determine whether or not a treatment was working soon after it was started would allow clinicians to identify which children need to be put onto stronger treatments earlier. \n\nWe propose that the same tests of inflammation in stool used for diagnosis could be used for this purpose, and that parents could collect specimens at home and post them to a laboratory, thereby minimising the testing’s impact on family life. By testing this approach in a relatively small number of children with IBD we will generate essential data that could be accessed by all researchers to help them identify ways to get children with IBD onto the best personalised treatment for them as quickly as possible.\n\nWe will follow 100 children with newly diagnosed IBD from participating NHS hospitals (200 children will be prospectively recruited prior to diagnostic endoscopy). Families will be asked to post anonymised stool samples to a central laboratory at five timepoints: Before scheduled endoscopy (performed for clinical reasons to confirm diagnosis), and at 14, 28, 42, and 56 days following initiation of treatment. The study involves no alteration to standard care based on clinical need, no additional visits to hospital, and no invasive sampling. Members of the clinical team will monitor clinical progress over the telephone or in person as determined by clinical need. An anonymised minimal clinical dataset will be published with results of the study in order to help researchers build on the results of this study.\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0392
Date of REC Opinion
22 Aug 2017
REC opinion
Favourable Opinion