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

NCT03069976 | Completed DMC

• 1 other identifier: OS.ABBA.CH.1618
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Sclerosing Cholangitis; Autoimmune Hepatitis; Overlap Syndrome

Outcome Measures

Primary Outcomes (1)

• Liver function test

  AST, ALT, GGT to be measured

  14 days

Secondary Outcomes (2)

• Microbiome

  14 days

• Bile acid profile

  14 days

Study Arms (1)

1

EXPERIMENTAL

All included patients, diagnosed with Overlap Syndrome or Primary Sclerosing Cholangitis, will receive treatment (Metronidazole x 14 days) hence single arm study.

Drug: Metronidazole

Interventions

Metronidazole DRUG

Flagyl x 14 days.

Also known as: Flagyl

1

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc - Université Catholique de Louvain

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing; Hepatitis, Autoimmune

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Hepatitis, Chronic; Hepatitis; Liver Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Etienne Sokal, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: January 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)