Prospective comparison of diagnostic tests for bile acid diarrhoea

Christian Borup*, Lars Vinter-Jensen, Søren Peter German Jørgensen, Signe Wildt, Jesper Graff, Tine Gregersen, Anna Zaremba, Trine Borup Andersen, Camilla Nøjgaard, Hans Bording Timm, Antonin Lamazière, Dominique Rainteau, Svend Høime Hansen, Jüri Johannes Rumessen, Lars Kristian Munck

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

3 Citations (Scopus)
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Abstract

BACKGROUND: Bile acid diarrhoea is often missed because gold standard nuclear medicine tauroselcholic [75-Se] acid (SeHCAT) testing has limited availability. Empirical treatment effect has unknown diagnostic performance, whereas plasma 7α-hydroxy-4-cholesten-3-one (C4) is inexpensive but lacks sensitivity.

AIMS: To determine diagnostic characteristics of empirical treatment and explore improvements in diagnostics with potential better availability than SeHCAT.

METHODS: This diagnostic accuracy study was part of a randomised, placebo-controlled trial of colesevelam. Consecutive patients with chronic diarrhoea attending SeHCAT had blood and stool sampled. Key thresholds were C4 > 46 ng/mL and SeHCAT retention ≤10%. A questionnaire recorded patient-reported empirical treatment effect. We analysed receiver operating characteristics and explored machine learning applied logistic regression and decision tree modelling with internal validation.

RESULTS: Ninety-six (38%) of 251 patients had SeHCAT retention ≤10%. The effect of empirical treatment assessed with test results for bile acid studies blinded had 63% (95% confidence interval 44%-79%) sensitivity and 65% (47%-80%) specificity; C4 > 46 ng/mL had 47% (37%-57%) and 92% (87%-96%), respectively. A decision tree combining C4 ≥ 31 ng/mL with ≥1.1 daily watery stools (Bristol type 6 and 7) had 70% (51%-85%) sensitivity and 95% (83%-99%) specificity. The logistic regression model, including C4, the sum of measured stool bile acids and daily watery stools, had 77% (58%-90%) sensitivity and 93% (80%-98%) specificity.

CONCLUSIONS: Diagnosis of bile acid diarrhoea using empirical treatment was inadequate. Exploration suggested considerable improvements in the sensitivity of C4-based testing, offering potential widely available diagnostics. Further validation is warranted.

CLINICALTRIALS: gov: NCT03876717.

Original languageEnglish
JournalAlimentary Pharmacology & Therapeutics
Volume59
Issue number1
Pages (from-to)39-50
Number of pages12
ISSN0269-2813
DOIs
Publication statusPublished - Jan 2024

Bibliographical note

© 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

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