Bile Acid MalabsorptionPhase 4BACHNCT03168555
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
A Phase 4 study testing chenodeoxycholic acid in people with Bile Acid Malabsorption and Cholelithiasis, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bile Acid Malabsorption, Cholelithiasis
- What is being tested?
- chenodeoxycholic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jun 2017to 15 May 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned elective cholecystectomy
Who cannot join
- small bowel resection
- right sided hemicolectomy
- known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory bowel diseases, incl microscopic colitis)
- pregnancy
- wish for pregnancy within next three months
- allergy to eggs
Show all 12Show fewer
- allergy to constituents in Xenbilox (capsules with chenodeoxycholic acid)
- acute cholecystitis within two months
- chronic cholecystitis
- cirrhosis of the liver
- suspected obstructive choledocholithiasis
- icterus
Trial locations and contacts
1 site in 1 country.
About this study
Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy
Read the detailed description
Lack of FGF19 and elevated 7-alpha-hydroxy-colestenone (C4) is associated with the bile acid diarrhoea (BAD), a disease with increasing estimated of prevalence.
BAD is occasionally triggered by cholecystectomy and FGF19 and C4 is known to be affected by cholecystectomy. The investigators are exploring if FGF19 after oral stimulation can be developed to a universal test for BAD, and need to know how the proposed test is affected by cholecystectomy.
- Conditions
- Bile Acid Malabsorption, Cholelithiasis
- Being tested
- chenodeoxycholic acid
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chenodeoxycholic acidDrug
Also called CDCA, chenodeoxycholate
1250 mg CDCA is given with a study meal
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | chenodeoxycholic acid 1250mg po. Receives: Drug: chenodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy
Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation)
Measured: baseline and 3 - 5 months after cholecystectomy
Secondary outcomes (10)
Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy
Change from baseline to after cholecystectomy in median unconjugated CDCA plus meal stimulated absorption of unconjugated CDCA to measured in plasma (total area under the CDCA curve with measurement at fasting ie. t=0 minutes and subsequently at 60, 90, 120, and finally at 150minutes.
Measured: baseline and 3 - 5 months after cholecystectomy
Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
Change from baseline to after cholecystectomy in fasting C4
Measured: baseline and 3 - 5 months after cholecystectomy
Change in Lipid Status From Baseline Before Versus After Cholecystectomy
Change from baseline to after cholecystectomy in plasma triglycerides
Measured: baseline and 3 - 5 months after cholecystectomy
Change in Stool Frequency From Baseline Before Versus After Cholecystectomy
Change from baseline to after cholecystectomy in number of stools as a mean of a seven-day diary baseline versus after cholecystectomy. That is the diary results for each study participant is tallied using mean values. The tallying of these diary results is done using medians. Therefore the unit used is 'mean stools per day' and this is reported with medians
Measured: baseline and 3 - 5 months after cholecystectomy
Change in Stool Pattern Correlated to FGF19
Spearman correlation between change from baseline to after cholecystectomy in FGF19 and in mean number of stools
Measured: baseline and 3 - 5 months after cholecystectomy
Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy
Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting C4 before versus after cholecystectomy
Measured: baseline and 3 - 5 months after cholecystectomy
Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy
Change in total AUC for C4 between visit 1 and visit 2
Measured: before cholecystectomy and 3-5 months after cholecystectomy
Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy
change in fasting FGF19 before versus after cholecystectomy
Measured: before and 3-5 months after cholecystectomy
Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy
Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting FGF19 before versus after cholecystectomy
Measured: baseline and 3 - 5 months after cholecystectomy
Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy
Change from baseline to after cholecystectomy in mean Bristol type per stool as of a seven-day diary baseline versus after cholecystectomy. The Bristol scale divides stool into seven categories from 1 (hard lumps) to 7 (completely watery stool). The diary shows pictograms with short text descriptions.
Measured: baseline and 3 - 5 months after cholecystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start22 Jun 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bile Acid MalabsorptionStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Borup, Principal investigator, Zealand University Hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168555
- Sponsor's protocol ID
- SJ-434
- Other IDs
- 2016-004692-53, 2016
- Acronym
- BACH
- Status last verified
- Jul 2021
- First submitted
- 22 May 2017
- Last updated
- 19 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
- ClinicalTrials.gov ID
- NCT03168555
- Acronym / sponsor ID
- BACH / SJ-434
- Conditions
- Bile Acid Malabsorption, Cholelithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 19 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy
Detailed description
Lack of FGF19 and elevated 7-alpha-hydroxy-colestenone (C4) is associated with the bile acid diarrhoea (BAD), a disease with increasing estimated of prevalence.
BAD is occasionally triggered by cholecystectomy and FGF19 and C4 is known to be affected by cholecystectomy. The investigators are exploring if FGF19 after oral stimulation can be developed to a universal test for BAD, and need to know how the proposed test is affected by cholecystectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: chenodeoxycholic acidchenodeoxycholic acid 1250mg po. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- planned elective cholecystectomy
Key exclusion criteria (12 listed)
- small bowel resection
- right sided hemicolectomy
- known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory bowel diseases, incl microscopic colitis)
- pregnancy
- wish for pregnancy within next three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chenodeoxycholic acidAlso: CDCA, chenodeoxycholate1250 mg CDCA is given with a study meal | Drug | Intervention |
Primary outcome
Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation)
10 secondary outcomes
Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Change in Lipid Status From Baseline Before Versus After Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Change in Stool Frequency From Baseline Before Versus After Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Change in Stool Pattern Correlated to FGF19
Time frame: baseline and 3 - 5 months after cholecystectomy
Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy
Time frame: before cholecystectomy and 3-5 months after cholecystectomy
Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy
Time frame: before and 3-5 months after cholecystectomy
Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy
Time frame: baseline and 3 - 5 months after cholecystectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Borup principal investigator
Zealand University Hosipital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chenodeoxycholic acid in people with Bile Acid Malabsorption and Cholelithiasis, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy (time frame: baseline and 3 - 5 months after cholecystectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.