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Pre-analytical Influences on a Blood Test Study

NCT05434949 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • IBS - Irritable Bowel Syndrome

Interventions

DIAGNOSTIC_TEST

Blood test

Three blood samples to be taken at 08.00, 10.00 and 12.00 on day 1 of the study. The following day, after an overnight fast, a blood sample will be taken at 8.00, followed by a standardized breakfast provided by the study team at 8.30, and then two further blood samples at 10.00 and 12.00.

OTHER

Analyses of samples

C4 will be measured in surplus serum from 30 adult lipid patients before starting on lipid-lowering therapy (either statin of PCSK9 therapy) and then again 3 months after starting on therapy. Blood samples will be collected as part of routine lipid management, no additional samples are required.

Sponsors & Collaborators

  • The Royal Wolverhampton Hospitals NHS Trust

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-11-15
Completion
2024-11-15

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434949 on ClinicalTrials.gov