NCT03059537

Brief Summary

This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250 mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species including 7-alpha-CHO and serial blood samples after the stimulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

February 2, 2017

Last Update Submit

December 11, 2017

Conditions

Bile Acid Malabsorption

Outcome Measures

Primary Outcomes (1)

  • Negative predictive value of stimulated deltaFGF19

    For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT \< 10 %

    Individual data are collected within one week

Secondary Outcomes (8)

  • Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%

    Individual data are collected within one week

  • Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%

    Individual data are collected within one week

  • Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%

    Individual data are collected within one week

  • Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%

    Individual data are collected within one week

  • Correlation of FGF19 to clinical diarrhoea

    Individual data are collected within one week

  • +3 more secondary outcomes

Study Arms (1)

Stimulation Test

EXPERIMENTAL

Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation

Drug: Oral chenodeoxycholic acid stimulation

Interventions

Oral chenodeoxycholic acid stimulationDRUG

oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor

Also known as: Chenodeoxycolic acid
Stimulation Test

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Consecutive patients referred for SeHCAT

You may not qualify if:

  • Treatment with sequestrants within one week before the SeHCAT.
  • Treatment with any constipants/laxatives one day before the SeHCAT, with the exception of opioids, if the dosis has been stable in the prior 2 weeks.
  • Breastfeeding women.
  • Small bowel resection, including right sided hemicolectomy.
  • Any ongoing treatment for inflammatory bowel disease with systemic steroids (i.e. budesonide or prednisone) or treatment in the prior 4 weeks.
  • Allergies to constituents of Xenbilox: (chenodeoxycholic acid, cornflour, magnesium stearate, highly dispersed silica, gelatine, sodium dodecylsulphate, titanium dioxide (E171), quinolone yellow (E104), erythrosine (E127)
  • Chronic or acute cholecystitis.
  • Liver cirrhosis,
  • Obstructed bile flow causing jaundice or elevated p-bilirubin (\> 1,5 UNL).
  • Known disability in gall bladder contractility.
  • Bile duct atresia.
  • Frequent gallstone attacks (\>2/month).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Zealand University Hopsital

Holbæk, 4300, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (1)

  • Borup C, Wildt S, Rumessen J, Graff J, Bouchelouche PN, Andersen TB, Vinter-Jensen L, Zaremba A, German Jorgensen SP, Gregersen T, Nojgaard C, Timm HB, Rainteau D, Gauliard E, Munck LK. Biochemical Diagnosis of Bile Acid Diarrhea: Prospective Comparison With the 75Seleno-Taurohomocholic Acid Test. Am J Gastroenterol. 2020 Dec;115(12):2086-2094. doi: 10.14309/ajg.0000000000000772.

    PMID: 32740083DERIVED

Study Officials

  • Christian Borup, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DMSci

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 23, 2017

Study Start

March 13, 2017

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)