To comprehensively profile the VOCs pattern in patients with PSC to get more insight in the etiology/pathogenesis of the disease, in particular the role of inflammation and gut microbiome.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VOCs pattern measured using Solid Phase Microextraction (SPME) in combination
with Gas Chromatography coupled with time-of-flight-Mass Spectrometry
(GC-tof-MS).
Secondary outcome
Various metabolites and biomarkers in the blood and fecal samples.
As well as a one leaflet questionnaire containing questions about BMI, age,
smoking & diet behavior and the Amsterdam Cholestatic Complaints Score and/or
the Simple Clinical Colitis Activity Index.
Background summary
Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic disease with
multiple stenosis and segmental dilatations of the bile ducts. This liver
disease is characterized by inflammation and fibrosis of both intrahepatic and
extrahepatic bile ducts, leading to the formation of multifocal bile duct
strictures. PSC ultimately can lead to cirrhosis, liver failure, malignancy and
death (1). The etiology of PSC remains unknown.
In the current study the hypothesis is that that an on-going inflammatory
stimulus, perhaps originating in the colon via *leaky gut hypothesis*, supports
bile duct inflammation. Therefore, although PSC has a wide range of
presentations, varying from no or little symptoms to severe cholestasis and/or
portal hypertension, on-going inflammation is the common denominator.
Therefore, integrated analysis of volatiles molecules in exhaled breath and
feces in combination with fecal microbiome and blood plasma metabolites we hope
to diagnose PSC at early, perhaps asymptomatic stage.
Study objective
To comprehensively profile the VOCs pattern in patients with PSC to get more
insight in the etiology/pathogenesis of the disease, in particular the role of
inflammation and gut microbiome.
Study design
Case-Control study in which exhaled VOCs patterns and fecal and blood
metabolites of PSC patients (cases) are compared to UC patients (controls) and
healthy controls.
Study burden and risks
The risk is limited to the chance of development of an hematoma after vena
puncture.
It is necessary to perform the current study in this population because it is
the population of interest (PSC patients). To identify PSC specific biomarkers
we have to compare the VOCs patterns of PSC patients to ulcerative colitis
patients and to healthy controls.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Cases: Ulcerative colitis with or without PSC
Controls (UC): Ulcerative colitis
Controls (healthy): Able to give informed consent.
Exclusion criteria
* Any disease compromising immune system (such as HIV positive status or
patients after organ transplantations).
* Any other liver disease
* Active and untreated tuberculosis
* Use of chemotherapy agents
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64879.018.18 |