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

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ClinicalTrials.gov Identifier: NCT03069976
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
Liver function test [ Time Frame: 14 days ]
AST, ALT, GGT to be measured
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03069976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
  • Microbiome [ Time Frame: 14 days ]
    Intestinal microflora to be characterized
  • Bile acid profile [ Time Frame: 14 days ]
    Bile acids profile to be characterized
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"
Official Title  ICMJE " Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Modification With Antibiotics in Children"
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Sclerosing Cholangitis
  • Autoimmune Hepatitis
  • Overlap Syndrome
Intervention  ICMJE Drug: Metronidazole
Flagyl x 14 days.
Other Name: Flagyl
Study Arms  ICMJE Experimental: 1
All included patients, diagnosed with Overlap Syndrome or Primary Sclerosing Cholangitis, will receive treatment (Metronidazole x 14 days) hence single arm study.
Intervention: Drug: Metronidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julia Versavau, Nurse + 32 2 764 19 33 pcic-saintluc@uclouvain.be
Contact: vanessa Jacobs, Nurse 1336 pcic-saintluc@uclouvain.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03069976
Other Study ID Numbers  ICMJE OS.ABBA.CH.1618
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Etienne Sokal, MD, PhD Cliniques universitaires Saint-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP