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NCT05434949

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
The Royal Wolverhampton Hospitals NHS Trust·ClinicalTrials.gov·diagnostic testNot yet recruiting
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Study focus
Disease/Condition
IBS - Irritable Bowel Syndrome
Drug/Device/Intervention
Blood test
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
The Royal Wolverhampton Hospitals NHS Trust
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2022
End date
Dec 01, 2024
Enrollment
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 syndromeIrritable bowel syndrome with predominant diarrhoea [IBS-D]Irritable bowel syndrome with mixed bowel habits [IBS-M]Other and unspecified irritable bowel syndrome
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05434949
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.