Trial to validate a method based on a blood sample to diagnose the disease bile acid diarrhoea

Validation of stimulated ?FGF19 for diagnosing bile acid diarrhoea - VABAD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002217-22-DK

Enrollment

Registered

2016-06-03

Start date

2016-09-02

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile acid malabsorption / bile acid diarrhoea MedDRA version: 19.1 Level: PT Classification code 10069703 Term: Bile acid malabsorption System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.1 Level: LLT Classification code 10066557 Term: Chronic diarrhoea System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Xenbilox / Chenodeoxycholic acid Product Name: xenbilox Product Code: PZN: 05484764 Pharmaceutical Form: Capsule INN or Proposed INN: chenodeoxycholic acid CAS Number: 474-25-9 Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: referral to SeHCAT for investigation of chronic watery diarrhoea Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Treatment with sequestrants or constipants/laxatives within one week before the SeHCAT. Pregnancy. Small bowel resection. Untreated active small bowel disease such as Crohns’ disease. Age 80 years.

Design outcomes

Primary

Measure	Time frame
Main Objective: Validation of stimulated ?FGF19 for diagnosis of BAD in patients referred to SeHCAT;Secondary Objective: correlation of ?FGF19 to fasting 7a-hydroxy-4-cholesten-3-on (C4). Correlation of all the above to diarheoa.;Primary end point(s): Negative predictive value of stimulated ?FGF19 >2.5pg/mL for detecting BAD defined by SeHCAT < 10%. ;Timepoint(s) of evaluation of this end point: after inclusion is completed.	—

Measure

Time frame

Main Objective: Validation of stimulated ?FGF19 for diagnosis of BAD in patients referred to SeHCAT;Secondary Objective: correlation of ?FGF19 to fasting 7a-hydroxy-4-cholesten-3-on (C4). Correlation of all the above to diarheoa.;Primary end point(s): Negative predictive value of stimulated ?FGF19 >2.5pg/mL for detecting BAD defined by SeHCAT < 10%. ;Timepoint(s) of evaluation of this end point: after inclusion is completed.

—

Secondary

Measure	Time frame
Secondary end point(s): • Positive predictive value of stimulated ?FGF19 >2.5pg/mL for detecting BAD defined by SeHCAT 5.5ng/mL for detecting BAD defined by SeHCAT 2.5pg/mL for detecting BAD defined by SeHCAT 5.5ng/mL for detecting BAD as compared to SeHCAT 5-10%, >10-15%, > 15%. ;Timepoint(s) of evaluation of this end point: after inclusion is completed and through the data analysis	—

Countries

Denmark

Contacts

Public ContactDepartement of internal medicine

Sjællands University Hospital, Køge

christianborup@hotmail.com004547322400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026