"Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"
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| ClinicalTrials.gov Identifier: NCT03069976 |
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Recruitment Status :
Recruiting
First Posted : March 3, 2017
Last Update Posted : April 8, 2019
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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 |
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 (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 |
|---|---|
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Experimental: 1
All included patients, diagnosed with Overlap Syndrome or Primary Sclerosing Cholangitis, will receive treatment (Metronidazole x 14 days) hence single arm study.
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Drug: Metronidazole
Flagyl x 14 days.
Other Name: Flagyl |
- Liver function test [ Time Frame: 14 days ]AST, ALT, GGT to be measured
- Microbiome [ Time Frame: 14 days ]Intestinal microflora to be characterized
- Bile acid profile [ Time Frame: 14 days ]Bile acids profile to be characterized
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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
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 ClinicalTrials.gov identifier (NCT number): NCT03069976
| Contact: Julia Versavau, Nurse | + 32 2 764 19 33 | pcic-saintluc@uclouvain.be | |
| Contact: vanessa Jacobs, Nurse | 1336 | pcic-saintluc@uclouvain.be |
| Belgium | |
| Cliniques Universitaires Saint-Luc - Université Catholique de Louvain | Recruiting |
| Brussel, Bruxelles, Belgium, 1200 | |
| Contact: Etienne Sokal, Dr. PhD +32 2 764 1387 etienne.sokal@uclouvain.be | |
| Contact: Julia Versavau, Nurse + 32 2 764 19 33 pcic-saintluc@uclouvain.be | |
| Principal Investigator: | Etienne Sokal, MD, PhD | Cliniques universitaires Saint-Luc |
| Responsible Party: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| ClinicalTrials.gov 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 |
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Bile Duct Diseases Anti-Infective Agents Cholangitis Cholangitis, Sclerosing Hepatitis, Autoimmune Undifferentiated Connective Tissue Diseases Syndrome Disease Pathologic Processes Hepatitis Liver Diseases |
Digestive System Diseases Biliary Tract Diseases Hepatitis, Chronic Autoimmune Diseases Immune System Diseases Connective Tissue Diseases Anti-Bacterial Agents Metronidazole Antiprotozoal Agents Antiparasitic Agents |