Pre-analytical Influences on a Blood Test Study
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Trial details
- Who runs it
- The Royal Wolverhampton Hospitals NHS Trust
- Trial code
- NCT05434949
- Record updated
- 15 January 2025
- Original description
Chronic diarrhoea is common and often believed to result from irritable bowel syndrome (IBS). However, up to 50% of patients with an IBS diagnosis may have something called Bile Acid Diarrhoea (BAD) instead. BAD is easily treatable however diagnosis currently relies on a complex test involving two full body scans. The aim of the study is therefore to investigate whether a simple laboratory test, that can be done on a single blood sample, would be appropriate instead. This laboratory test is called 7aC4.Read full original descriptionShow less
Effect of Post-prandial State, Statins and PCSK9 Inhibitors on Serum 7a-hydroxy-4-cholesten-3-one Concentration
Chronic diarrhoea is common and often believed to result from irritable bowel syndrome (IBS). However, up to 50% of patients with an IBS diagnosis may have something called Bile Acid Diarrhoea (BAD) instead. BAD is easily treatable however diagnosis currently relies on a complex test involving two full body scans. The aim of the study is therefore to investigate whether a simple laboratory test, that can be done on a single blood sample, would be appropriate instead. This laboratory test is called 7aC4.
In order to determine whether 7aC4 could be a good test for BAD, it needs to be determined whether eating a meal can alter the levels of 7aC4. The aim of this study is to measure 7aC4 at several time points before and after eating a meal, to see what effect this has on 7aC4 levels.
Inclusion: Part 1: Effect of food intake on C4; Healthy adult (>=18 years) volunteers from the BCPS; Part 2: Effect of Lipid-lowering therapy on C4; There is no patient recruitment. Spare sample collected from patients before and after starting on lipid-lowering therapy will be used.
Exclusion: On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism; Previous ileal resection or cholecystectomy; Lipid lowering therapy within the last 6 months for the first sample; On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism; Previous ileal resection or cholecystectomy; Gastrointestinal disease; Gastrointestinal disease; Part 1: Effect of food intake on serum C4; Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2; Part 2: Effect of Lipid-lowering therapy on C4; The surplus serum will not be analysed if any of the following apply to the patient:; Subjects with learning disability or those lacking mental capacity to give consent; Pregnant or breast-feeding; Chronic and acute diarrhoea; Pregnant or breastfeeding for either time point; Chronic and acute diarrhoea; Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2.