Serum Metabolics-based Method for Diagnosing Bile Acid Diarrhoea

NCT06548009 | Completed

• 1 other identifier: BAD-DIVA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

Bile acid diarrhoea (BAD) is a common yet under-diagnosed and under-recognised disease. The primary symptoms are watery diarrhoea with high frequency of unpredictable bowel movements,urgency and faecal incontinence making BAD a debilitating condition. One of the challenges of BAD is the lack of a readily available and accurate diagnostic test. The aim of this study is to validate a BAD diagnostic score (BDS) based on metabolomics.

Conditions

Bile Acid Malabsorption; Bile Acid Diarrhea

Keywords

bile acid; diarrhea; diagnostics

Outcome Measures

Primary Outcomes (1)

• AUROC curve of the BDS in the validation cohort

  AUROC curve of the BDS in the validation cohort

  1 year from now

Secondary Outcomes (5)

• AUROC curve of BDS in patients with each of the three subtypes of BAD

  1 year from now

• AUROC curve of BDS in the discovery cohort (see 8.2 Data analysis)

  1 year from now

• Correlation of SeHCAT test result with severity of BAD symptoms

  1 year from now

• Correlation of BDS test results with number of stools per day

  1 year from now

• Biomarkers for BAD: C4 and FGF19

  1 year from now

Study Arms (2)

SeHCAT confirmed bile acid diarrhea

Patients referred to a SeHCAT scan due to suspected bile acid diarrhea, who afterwards turned out to be suffering from SeHCAT confirmed bile acid diarrhea

Diagnostic Test: Metabolomics and other blood samples

SeHCAT negative patients

Patients referred to a SeHCAT scan due to suspected bile acid diarrhea, who afterwards turned out to be SeHCAT negative

Diagnostic Test: Metabolomics and other blood samples

Interventions

Metabolomics and other blood samples DIAGNOSTIC_TEST

Blood samples taken with the objective of identifying a diagnostic test

SeHCAT confirmed bile acid diarrhea; SeHCAT negative patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of SeHCAT referred patients for suspected bile acid diarrhoea.

You may qualify if:

• SeHCAT referral for suspected bile acid diarrhoea
• Age ≥18 years

You may not qualify if:

• Diabetes, except type 2 diabetes
• Nephropathy with estimated glomerular filtration rate \<30 min/1.73 m2
• Treatment with medicine that cannot be paused for 12 hours
• Hypothyroidism or hyperthyroidism, if not well regulated
• Active or recent (\<6 months since last treatment) malignant disease
• Any treatment or condition requiring acute or subacute medical or surgical intervention
• Any condition considered incompatible with trial participation by the investigators

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (3)

Bispebjerg and Frederiksberg Hospital

Copenhagen, Denmark

Location

Herlev Gentofte Hospital

Hellerup, Denmark

Location

Hillerød Hospital

Hillerød, Denmark

Location

Related Publications (1)

• Lewinska M, Karhus ML, Ellegaard AG, Romero-Gomez M, Macias RIR, Andersen JB, Knop FK. Serum lipidome unravels a diagnostic potential in bile acid diarrhoea. Gut. 2023 Sep;72(9):1698-1708. doi: 10.1136/gutjnl-2022-329213. Epub 2023 Apr 18.

  PMID: 37072179 BACKGROUND

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: August 12, 2024
• Study Start: May 31, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)