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Randomized Controlled Trial
. 2024 Jan;59(1):39-50.
doi: 10.1111/apt.17739. Epub 2023 Oct 5.

Prospective comparison of diagnostic tests for bile acid diarrhoea

Christian Borup  1   2 , Lars Vinter-Jensen  3 , Søren Peter German Jørgensen  4 , Signe Wildt  5 , Jesper Graff  6 , Tine Gregersen  7 , Anna Zaremba  3 , Trine Borup Andersen  8 , Camilla Nøjgaard  5 , Hans Bording Timm  5 , Antonin Lamazière  9 , Dominique Rainteau  9 , Svend Høime Hansen  10 , Jüri Johannes Rumessen  1 , Lars Kristian Munck  1   2
Affiliations
Randomized Controlled Trial

Prospective comparison of diagnostic tests for bile acid diarrhoea

Christian Borup et al. Aliment Pharmacol Ther. 2024 Jan.

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.

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