Identification of microbiota-specific mucosal immune responses driving primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease (IBD).<br>

Completed

• Conditions: inflammatory bowel disease with bile duct and/or liver disease; 10017969; 10019654

• Registration Number: NL-OMON42112
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

-Diagnosis of PSC according to generally accepted criteria (EASL diagnostic guidelines): presence of elevated serum markers of cholestasis (ALP, GGT) not otherwise explained, when MRCP or ERCP show characteristic bile duct changes with multifocal strictures and segmental dilatations, and causes of secondary sclerosing cholangitis and other cholestatic disorders are excluded;
-IBD (CD, UC or indeterminate colitis) confirmed by clinical evaluation in combination with endoscopic and histological investigations;
-Informed consent by patients or, when applicable, parents.

Exclusion Criteria

-Diagnosis of immunodeficiency syndromes;
-Secondary causes of sclerosing cholangitis;
-Evidence of decompensated liver disease such as previous variceal bleeding, ascites, or hepatic encephalopathy;
-Anticipated need for liver transplantation within one year; after liver transplantation these patients will be eligible again.
-Findings highly suggestive of liver disease of an alternative or concomitant etiology, such as alcoholic liver disease, hepatitis B or C, haemochromatosis, Wilson*s disease, a1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis;
-Pregnant or lactating patients;
-Active illicit drug or alcohol abuse;
-Suspicion of ascending cholangitis or acute (septic) cholangitis or one of these events in the previous 6 months;
-Any infection necessitating antibiotics use >14 days in the previous 6 months.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim is to characterize mucosal immune responses in concomitant PSC<br /><br>and IBD</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Number and phenotype of immune cells (neutrophils, monocytes, mucosal T-cells)<br /><br>in peripheral blood, intestinal tissue and liver tissue;<br /><br>-Base-line levels of cytokines of mucosal T-cells from peripheral blood and<br /><br>intestinal biopsies;<br /><br>-The immunological response of mucosal T-cells from peripheral blood and<br /><br>intestinal tissue upon re-stimulation with superantigens or microbial peptides;<br /><br>-Extent of microbial translocation in peripheral blood (measured with 16S rDNA<br /><br>translocation assay);<br /><br>-Serological parameters (i.e. anti-flagellin antibodies);</p><br>