"Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"

Primary Sclerosing Cholangitis Clinical Trial

Official title:

" Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Modification With Antibiotics in Children"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069976
• Other study ID #: OS.ABBA.CH.1618
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2021

Study information

• Verified date: August 2022
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based upon the possible implication of microbiota and abnormal microbial metabolites such as altered bile acids, in the pathogenesis of PSC, emerging data suggests that oral antibiotics, such as vancomycin and metronidazole, may have therapeutic effects in this overlap syndrome or PSC.

The goal of our study is to evaluate role of antibiotics and microflora in children with AIH/PSC overlap syndrome or with PSC alone. The investigators hope to learn what effects oral antibiotics has on the bacteria present in stool, and hope to learn to characterize human intestinal microbial communities, in children suffering from overlap syndrome or PSC.

The hypothesis of the investigators is that overlap syndrome and PSC develop due to altered microflora and the resulting abnormal bile acids pool. The outcome of overlap syndrome or PSC could be affected by presence or absence of RCUH. Antibiotics to correct the microflora may result in disease/cholangiopathy remission.

Description:

The used antibiotic is Metronidazole (Flagyl), during 14 days, as induction therapy or rescue therapy.

Study participants will provide blood and stool samples in order to evaluate bile acids profile and microbiome, before and after the course of metronidazole, and then comparison will be made pre- and post-antibiotics.

The investigators will determine the benefit of oral metronidazole therapy through improvement of clinical symptoms and improvement of liver function tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

Inclusion Criteria:

• Children diagnosed with overlap syndrome, overlap syndrome + ulcerative colitis (UC), Primary sclerosing cholangitis (PSC) or PSC + UC

• Children for whom consent is available

• Children under regular follow-up

• Children with at least one liver biopsy (for overlap syndrome patients)

• Children with at least one liver biopsy and one MRCP (for PSC patients)

Exclusion Criteria:

• Death

• Patients older than 18 years old at the time of diagnosis of liver disease

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Cholangitis
• Cholangitis, Sclerosing
• Hepatitis, Autoimmune
• Overlap Syndrome
• Primary Sclerosing Cholangitis
• Syndrome
• Undifferentiated Connective Tissue Diseases

Intervention

Drug:
• Metronidazole
Flagyl x 14 days.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc - Université Catholique de Louvain	Brussel	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function test	AST, ALT, GGT to be measured	14 days
Secondary	Microbiome	Intestinal microflora to be characterized	14 days
Secondary	Bile acid profile	Bile acids profile to be characterized	14 days