IBAD-C4: Ileal resection Bile Acid Diarrhoea - C4 validation.
Research type
Research Study
Full title
Validation of 7α-hydroxy-4-cholesten-3-one (C4) serum levels as a biomarker of Bile Acid Diarrhoea (BAD) following ileal resection in Crohn’s disease
IRAS ID
363908
Contact name
Laura Hancock
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Crohn’s disease (CD) is a chronic Inflammatory Bowel Disease (IBD) characterised by transmural granulomatous inflammation affecting anywhere along the entirety of the human gastrointestinal tract. It is a disease with no known cure, and treatment is focussed on suppressing the dysregulated immune response and managing complications of uncontrolled inflammation
The most common anatomical site affected at presentation is the terminal ileum of the small intestine. The terminal ileum has multiple functions in both disease and in healthy individuals. It plays a crucial role in the re-absorption of bile salts in the enterohepatic circulation. Bile salts, which are produced from cholesterol in the liver and stored in the gallbladder, aid digestion and absorption of dietary fats and fat-soluble vitamins in the bowel.
Diarrhoea is a common symptom following ileal bowel resection in CD. It can be difficult to distinguish whether this is due to the terminal ileum being removed, which can lead to Bile Acid Diarrhoea (BAD) due to the key role the bowel plays in re-absorbing bile acids made by the liver, or whether this is due to recurrence of CD after the surgery.
BAD has classically been diagnosed using a Se-homocholic acid-taurine (75SeHCAT) test. This has several limitations in that it is expensive, time consuming and difficult to interpret in the post operative setting. Serum C4 has shown excellent crossover with SeHCAT in relation to sensitivity and specificity in patients with idiopathic BAD.
Recent work from Wythenshawe has developed a high-throughput, quick, and reproducible liquid chromatography tandem mass spectrometry (LC-MS/MS) semi-automated process for quantifying C4 levels in a clinical laboratory setting.
Currently serum C4 has not been assessed in Crohn’s disease.
This study is designed to investigate whether serum C4 levels change following surgery for ileal CD and whether C4 can accurately and reliably diagnose BAD in patients following ileal resection surgery for CD.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0086
Date of REC Opinion
25 Jun 2026
REC opinion
Further Information Favourable Opinion