A Multicenter Prospective Study to Investigate the Diagnostic Accuracy of the SeHCAT Test in Measuring Bile Acid Malabsorption: Research Protocol

JMIR Research Protocols
Fiona ReidJennifer Summers

Abstract

Bile acid malabsorption (BAM) is one possible explanation for chronic diarrhea. BAM may be idiopathic, or result from ileal resection or inflammation including Crohn's disease, or may be secondary to other conditions, including cholecystectomy, peptic ulcer surgery, and chronic pancreatitis. No "gold standard" exists for clinical diagnosis of BAM, but response to treatment with a bile acid sequestrant (BAS) is often accepted as confirmation. The SeHCAT (tauroselcholic [selenium-75] acid) test uses a radiolabeled synthetic bile acid and provides a diagnostic test for BAM, but its performance against "trial of treatment" is unknown. Fibroblast growth factor 19 (FGF-19) and 7-alpha-hydroxy-4-cholesten-3-one (C4) also offer potential new biomarkers of BAM. This protocol describes a multicenter prospective study to evaluate the diagnostic accuracy of SeHCAT and 2 biomarkers in predicting BAM as assessed by trial of treatment. Participating gastroenterology centers should have a minimum workload of 30 SeHCAT patients per annum. Patients should not be pregnant, on medication that could confound follow-up, or have any severe comorbidity. All eligible patients attending a gastrointestinal appointment will be invited to participate. On a...Continue Reading

References

Apr 1, 1992·Postgraduate Medical Journal·G A FordS P Wilkinson
May 12, 2009·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Julian R F WaltersCarel W le Roux
Nov 11, 2009·British Medical Bulletin·Sanjeev Pattni, Julian R F Walters
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Feb 15, 2013·Nuclear Medicine Communications·Michael J Smith, Alan C Perkins

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Citations

Jun 3, 2016·BMJ Open Gastroenterology·Jennifer A SummersFiona Reid
Feb 6, 2020·Journal of the Canadian Association of Gastroenterology·Daniel C SadowskiJulian R F Walters

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Methods Mentioned

BETA
enzyme-linked immunosorbent assay

Software Mentioned

SeHCAT

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