Oral Microbiome of Patients With Hepatitis C Virus Infection

NCT03682549 | Completed DMC

• 1 other identifier: A1PhD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatitis C virus (HCV) infection is very common in Egypt and the middle east. The disease affects multiple body organs and may proceed to hepatocellular carcinoma. The viral disease causes changes in the microbial symbiosis in the human body. Thus, the analysis of the microbiome may provide a means of diagnosis for HCV infection. Thus, this study will be held to detect if the microbiome of patients having HCV differ from that of normal individuals.

Conditions

Hepatitis C Viral

Outcome Measures

Primary Outcomes (1)

• Oral Microbiome dysbiosis

  changes in oral microbial composition will be analysed using bioinformatics tools to provide figures showing the extent of dysbiosis and its composition

  1 month

Study Arms (3)

HCV positive Patients

patients will be recruited from the outpatient's viral hepatitis clinic The patients will be diagnosed as HCV positive through (antiHCV-Ab) and (HCV-PCR) tests

Diagnostic Test: Oral microbiome analysis

Successfully treated former HCV patients

Patients formerly diagnosed as HCV positive who received DAA treatment successfully.

Diagnostic Test: Oral microbiome analysis

Normal Individuals

healthy volunteers recruited from the outpatient clinic of the Faculty of Dentistry- Cairo University

Diagnostic Test: Oral microbiome analysis

Interventions

Oral microbiome analysis DIAGNOSTIC_TEST

Oral swab from the buccal mucosa will be obtained and then analysed Oral Microbiome analysis:The microbial RNA will be sequenced using Next Generation Sequencer.

HCV positive Patients; Normal Individuals; Successfully treated former HCV patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be divided into three groups: Group I: Patients diagnosed with Hepatitis C virus. Group II: successfully treated chronic HCV patients Group III: Healthy individuals They will be asked to rinse gently, then buccal mucosal swabbing takes place.

You may qualify if:

• \. Patients 18 years or older. 2. Non-smokers

You may not qualify if:

• \. Patients who took any antibiotic or probiotics in the past month. 2. Patients having known active bacterial, fungal or other viral disease. 3. Patients having clinically apparent oral disease. 4. Patients undergoing radiotherapy

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry- Cairo University

Cairo, 11562, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

A Swab from the buccal mucosa

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 24, 2018
• Study Start: December 1, 2019
• Primary Completion: March 14, 2020
• Study Completion: March 14, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)