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Trial record 25 of 64 for:    "Bile Duct Disease" | "Anti-Infective Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03069976
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : April 8, 2019
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Autoimmune Hepatitis Overlap Syndrome Drug: Metronidazole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: " Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Modification With Antibiotics in Children"
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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 Name: Flagyl

Primary Outcome Measures :
  1. Liver function test [ Time Frame: 14 days ]
    AST, ALT, GGT to be measured

Secondary Outcome Measures :
  1. Microbiome [ Time Frame: 14 days ]
    Intestinal microflora to be characterized

  2. Bile acid profile [ Time Frame: 14 days ]
    Bile acids profile to be characterized

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03069976

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Contact: Julia Versavau, Nurse + 32 2 764 19 33
Contact: vanessa Jacobs, Nurse 1336

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Cliniques Universitaires Saint-Luc - Université Catholique de Louvain Recruiting
Brussel, Bruxelles, Belgium, 1200
Contact: Etienne Sokal, Dr. PhD    +32 2 764 1387   
Contact: Julia Versavau, Nurse    + 32 2 764 19 33   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Principal Investigator: Etienne Sokal, MD, PhD Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier: NCT03069976     History of Changes
Other Study ID Numbers: OS.ABBA.CH.1618
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bile Duct Diseases
Anti-Infective Agents
Cholangitis, Sclerosing
Hepatitis, Autoimmune
Undifferentiated Connective Tissue Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Biliary Tract Diseases
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents