Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.
This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.
Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.
To measure the reliability of pH testing to confirm ongoing nasogastric tube (NGT) position and to document associated complications.
Confirming NGT position is essential, as use of an incorrectly positioned tube can cause harm. Substantial evidence examines initial confirmation of NGT position, yet limited evidence exists considers NGT displacement which is identified via ongoing NGT position tests. In the NHS, pH testing is recommended to confirm ongoing NGT position; however, there may be an association with excess X-rays and missed enteral nutrition and/or medications.
Prospective observational study using STROBE checklist.
Data collected from medical records of 136 patients with NGTs in a London NHS Trust included pH tests, test results and complications related to ongoing pH tests which failed to confirm the tube was positioned in the stomach, that is, X-rays, and disruptions to enteral nutrition and medication. Cohen's Kappa determined pH test reliability.
Of 1381 pH tests conducted to confirm NGT position, five (0.3%) correctly identified an NGT displacement, and one (0.07%) failed to identify displacement before use. The reliability of ongoing pH tests using Cohen's Kappa was minimal (0.29). Ongoing pH tests that failed to confirm a correctly positioned NGT led to 31 (22.8%) patients having X-rays, 24 (17.6%) missing >10% of prescribed enteral nutrition and 25 (18.4%) missing a critical medication.
Ongoing NGT position testing using pH tests did not prevent the use of a displaced tube, and more than one-fifth of patients required X-rays to confirm a correctly position NGT, contributing to missed medications and enteral nutrition.
Caution should be used when confirming ongoing NGT position with a pH test. Future guidelines should balance the risk of using a displaced tube with potential delays to nutrition and/or medication. More research is needed to explore alternative methods of ongoing NGT position testing.