ClinicalTrials.gg
Active, not recruitingNCT03566797SSCproUpdated Oct 13, 2026

Secondary Sclerosis Cholangitis Prospective

An observational study in Secondary Sclerosis Cholangitis in Critically Ill Patients, sponsored by Medical University of Graz. Active, not recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Medical University of Graz · Observational

Updated Oct 13, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
01

Study summary

SC-CIP is increasing in patients after critical illness. Pathogenesis is still largely unclear. Gut microbiome composition, gut permeability, bacterial translocation, inflammation and/or genetic variants contribute to the pathogenesis The aim of this project is to study gut microbiome composition, gut permeability, bacterial translocation, inflammation, bile acid composition and genetic polymorphisms by conducting a prospective cohort study in patients with a high risk to develop SC-CIP.

Read the detailed description

Secondary sclerosing cholangitis in critically ill patients (SC-CIP) is a rare, quickly progressive, cholestatic liver disease which is observed in patients suffering from a severe illness with the need for long term treatment on an intensive care unit (ICU). Invasive ventilation, polytrauma, hypotension, systemic inflammatory response syndrome, burns, complex operations and severe (co-) morbidities such as obesity have been discussed as risk factors. Patients suffering from SC-CIP do not have any underlying liver disease. Usually, long- term ICU treatment is described as the trigger mechanism for the development of this disease, although also rapid development of SC-CIP after an ICU stay as short as nine days is described in a single case.

The pathogenesis of SC-CIP is not fully understood yet: Ischemic injury of the intrahepatic biliary system, bile cast formation and recurrent biliary infections are discussed as major factors. The disease leads to a progressive destruction of the intra- and extrahepatic biliary tree with the development of strictures resulting in liver fibrosis with in some cases rapid progression to cirrhosis with the need for liver transplantation within months. The gold standard for diagnosis is endoscopic retrograde cholangiopancreaticography (ERCP), although magnetic resonance cholangiopancreatography (MRCP) as non-invasive alternative can lead to the diagnosis in most cases. Prognosis is poor and transplant-free survival has been found to be 40 months in average. Liver transplantation is the only curative treatment, which shows excellent outcome and quality of life comparable to other indication for liver transplantation.

Microbiological analysis of bile from patients with SC-CIP and primary sclerosing cholangitis (PSC) show a significant different microbiological profile in these two cohorts with dominance of drug resistant organisms in the bile of SC-CIP. No data on the gut microbiome in SC-CIP are available so far. Other chronic liver diseases show distinct changes in microbiome composition with potential influence on the inflammation process in these liver diseases (non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease, PSC and liver cirrhosis). In general a decrease in diversity, a higher abundance of potentially pathogenic species and a lower abundance of beneficial species has been observed.

Dysbiosis is thought to increase intestinal permeability. Increased gut permeability is most frequently observed in liver cirrhosis but was also found in alcohol-induced injury, NAFLD and hepatitis C-mediated liver injury. With an impaired gut permeability bacteria from the intestinal lumen can be translocated into extraintestinal parts of the body (lymph nodes, blood) and prompt inflammatory responses. Genetic polymorphisms in the Nucleotide-binding oligomerization domain-containing protein 2 (NOD2) gene, a known risk factor for bacterial translocation, increases the odds of developing SC-CIP.

It is hypothesized that the gut microbiome composition is altered in SC-CIP and that this is associated with increased gut permeability and markers of inflammation. Reasons for this might lie in gene polymorphisms influencing bacterial translocation or bile acid composition.

The aim of this study is to prospectively assess the incidence of SC-CIP in a cohort of patients at risk for developing SC-CIP (ICU treatment with the need for mechanical ventilation or extracorporeal membrane oxygenation >/= 5 days) and study differences in gut microbiome composition, gut permeability, bacterial translocation, inflammation as well as genetic polymorphisms in patients developing SC-CIP and patients with comparable disease severity who did not develop SC-CIP.

02

Conditions studied

  • Secondary Sclerosis Cholangitis in Critically Ill Patients
03

In context

Cholangitis

82 studies on the registry are indexed under Cholangitis; 17 are open to participants now.

This study's planned enrollment of 380 is above the median of 250 across 27 observational studies indexed under Cholangitis.

Browse Cholangitis studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients admitted to Intensive Care Units at the University Hospital Graz

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is willing and able to give for participation in the study OR "surrogate consent" by the institutional review board.
  • Age above 18 years
  • Mechanical ventilation or extracorporeal membrane oxygenation >/= 5 days

Exclusion criteria

Exclusion Criteria:

  • Primary or secondary sclerosing cholangitis diagnosed before current ICU admission
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
380 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • SC-CIP

    Patients developing SC-CIP

  • noSC-CIP

    Patients with similar severity of critical illness not developing SC-CIP

06

What researchers measure

Primary outcomes

  1. Incidence of SC-CIP in patients at risk

    risk is defined as need for mechanical ventilation or extracorporeal membrane oxygenation \>/= 5 days

    Time frame: during hospital stay, on average 4 weeks

Secondary outcomes

  1. Gut microbiome composition

    16S rRNA sequencing

    Time frame: at inclusion

  2. Stool zonulin

    gut permeability marker, ELISA

    Time frame: at inclusion

  3. Stool calprotectin

    gut inflammation marker, ELISA

    Time frame: at inclusion

  4. Serum endotoxin

    bacterial translocation marker, cell-based assay

    Time frame: at inclusion

  5. Serum lipopolysaccharide binding protein

    bacterial translocation marker, ELISA

    Time frame: at inclusion

  6. soluble cluster of differentiation 14 (sCD14)

    bacterial translocation marker, ELISA

    Time frame: at inclusion

  7. bile acid transporter polymorphisms

    sequencing of bile acid transporter genes

    Time frame: at inclusion

  8. NOD2 polymorphisms

    sequencing of the NOD2 gene

    Time frame: at inclusion

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 13, 2026
Primary completion
Dec 2026→Dec 2028
Oct 13, 2026
Study completion
Dec 2027→Dec 2029
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Recruiting→Active, not recruiting
    Primary completion Dec 2026→Dec 2028
    Study completion Dec 2027→Dec 2029
    + 4 other changes: index terms, verification date, site details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT03566797
Responsible party
Sponsor
First posted
Jun 25, 2018
Start date
Jul 20, 2018
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Oct 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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