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Oral Microbiome of Patients With Hepatitis C Virus Infection

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682549
Recruitment Status : Completed
First Posted : September 24, 2018
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Ayat Gamal-AbdelNaser, Cairo University

Tracking Information
First Submitted Date September 21, 2018
First Posted Date September 24, 2018
Last Update Posted Date November 25, 2020
Actual Study Start Date December 1, 2019
Actual Primary Completion Date March 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2018)
Oral Microbiome dysbiosis [ Time Frame: 1 month ]
changes in oral microbial composition will be analysed using bioinformatics tools to provide figures showing the extent of dysbiosis and its composition
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Microbiome of Patients With Hepatitis C Virus Infection
Official Title Oral Microbiome of Patients With Chronic Hepatitis C Virus Infection: A Case-Control Study
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.

Detailed Description

Human oral cavity is a great habitat for more than 600 species of bacteria, known as oral microbiota, living in equilibrium. Oral microbiota plays an important role in maintaining oral health; however when the balance in oral bacterial population is disturbed- known as dysbiosis- oral and systemic diseases may arise.

Some systemic diseases were proven to be associated with oral dysbiosis. Among these diseases are diabetes mellitus, cardiovascular diseases, breast cancer, pancreatic cancer, autoimmune liver diseases, hepatic encephalopathy and hepatitis B infection.

Hepatitis C virus (HCV) is considered an epidemic disease in Egypt; affecting about 10% of Egyptians ranging between 15 and 59 years of age. HCV infection damages the liver progressively causing liver cirrhosis, hepatic encephalopathy and may proceed to hepatocellular carcinoma.

Due to being a serious disease, together with the promising results of the newly discovered directly acting antiviral agents in treatment of chronic HCV, medicine has been concerned with finding efficient methods for its early diagnosis; in order to ensure early effective treatment and prevent serious complications.

Evidence suggests that a link exists between dysbiotic oral microenvironment and liver disease through oral-liver-gut axis. Attempts have been made to investigate the complex oral microbiota. With the advent of whole-genome sequencing technology, the genome of microbes have been possible to be sequenced in what is known as microbiome. Analyzing the genome of complex environment containing multiple individual microbes is called metagenomics.

Oral microbiome depends on sequencing of the 16S rRNA to provide a map of all oral microbiota available in the oral cavity. The technology of oral microbiome sequencing advanced from Sanger sequencing, that had shallow sequencing effort, to high throughput sequencing combined with bioinformatic tools, that allowed for comprehensive study of the complex microbiome.

Dysbiosis has been used for diagnosis of liver diseases through stool analysis. Only one study used oral dysbiosis to diagnose hepatic encephalopathy and another one used it in testing hepatitis B infection. However, oral dysbiosis has not been used to diagnose HCV infection before.

Understanding the oral microbiome at state of health and its change at state of disease can help predict the early stages of disease and treat it before further damage and disease progression occur. It can also help treat each patient according to the specific microbiome detected through personalized medicine. Furthermore, targeted treatment to each patient's specific microbiome can be introduced using specific prebiotics and probiotics to maintain the bacterial symbiosis and so assist the immune system in its continuous antiviral battle.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
A Swab from the buccal mucosa
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.

Condition Hepatitis C Viral
Intervention Diagnostic Test: Oral microbiome analysis
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.
Study Groups/Cohorts
  • 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

    Intervention: Diagnostic Test: Oral microbiome analysis
  • Successfully treated former HCV patients
    Patients formerly diagnosed as HCV positive who received DAA treatment successfully.
    Intervention: Diagnostic Test: Oral microbiome analysis
  • Normal Individuals
    healthy volunteers recruited from the outpatient clinic of the Faculty of Dentistry- Cairo University
    Intervention: Diagnostic Test: Oral microbiome analysis
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 Completed
Actual Enrollment
 (submitted: November 23, 2020)
30
Original Estimated Enrollment
 (submitted: September 21, 2018)
20
Actual Study Completion Date March 14, 2020
Actual Primary Completion Date March 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03682549
Other Study ID Numbers A1PhD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ayat Gamal-AbdelNaser, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cairo University
Verification Date November 2020