Status:
COMPLETED
Pre-analytical Influences on a Blood Test Study
Lead Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Conditions:
IBS - Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Brief 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) i...
Detailed Description
Chronic diarrhoea is common and largely due to irritable bowel syndrome (IBS). IBS is reported to affect about 11% of the UK population. About half these patients are believed, however, to have bile a...
Eligibility Criteria
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
- Part 1: Effect of food intake on serum C4
- Subjects with learning disability or those lacking mental capacity to give consent.
- Pregnant or breast-feeding
- On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism.
- Chronic and acute diarrhoea
- Gastrointestinal disease.
- Previous ileal resection or cholecystectomy
- 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:
- Pregnant or breastfeeding for either time point
- 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.
- Chronic and acute diarrhoea
- Gastrointestinal disease.
- Previous ileal resection or cholecystectomy
- Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2
Key Trial Info
Start Date :
December 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05434949
Start Date
December 1 2022
End Date
November 15 2024
Last Update
January 15 2025
Active Locations (1)
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1
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP