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

August 4, 2022 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Bruxelles
      • Brussel, Bruxelles, Belgium, 1200
        • Cliniques universitaires Saint-Luc - Université catholique de Louvain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
All included patients, diagnosed with Overlap Syndrome or Primary Sclerosing Cholangitis, will receive treatment (Metronidazole x 14 days) hence single arm study.
Drug: Metronidazole
Flagyl x 14 days.
Other Names:
  • Flagyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function test
Time Frame: 14 days
AST, ALT, GGT to be measured
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome
Time Frame: 14 days
Intestinal microflora to be characterized
14 days
Bile acid profile
Time Frame: 14 days
Bile acids profile to be characterized
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Etienne Sokal, MD, PhD, Cliniques Universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS.ABBA.CH.1618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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