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Pre-analytical Influences on a Blood Test Study - Trial NCT05434949

Access comprehensive clinical trial information for NCT05434949 through Pure Global AI's free database. This phase not specified trial is sponsored by The Royal Wolverhampton Hospitals NHS Trust and is currently Not yet recruiting. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 40 participants.

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NCT05434949
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diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT05434949
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Pre-analytical Influences on a Blood Test Study
Effect of Post-prandial State, Statins and PCSK9 Inhibitors on Serum 7a-hydroxy-4-cholesten-3-one Concentration

Study Focus

Blood test

Observational

diagnostic test

Sponsor & Location

The Royal Wolverhampton Hospitals NHS Trust

Timeline & Enrollment

N/A

Dec 01, 2022

Dec 01, 2024

40 participants

Primary Outcome

Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake.,Measure increase/decrease in Serum C4 levels after taking lipid lowering therapy (statins / PCSK9 inhibitors).

Summary

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.

ICD-10 Classifications

Irritable bowel syndrome with predominant constipation [IBS-C]
Irritable bowel syndrome
Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Irritable bowel syndrome with mixed bowel habits [IBS-M]
Other and unspecified irritable bowel syndrome

Data Source

ClinicalTrials.gov

NCT05434949

Non-Device Trial