Study on Gut Microbiota in Chronic HBV Infected Patients (HBV)

July 3, 2018 updated by: Zhongshan Hospital Xiamen University

Study on Gut Microbiota in Chronic Hepatitis B Virus Infected Patients

Hepatitis B Virus(HBV) infection is a common infectious disease affecting up to 2 billion people worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver cancer caused by chronic hepatitis B every year. Age is the main factor affecting the chronicity of hepatitis B, while 90% and 25% to 30% of hepatitis b virus(HBV) infection in perinatal and infant period will develop into chronic infection respectively. Whereas the proportion in patients above 5 years old is only 5% to 10%. Intestinal microbiota plays an important role in maintaining nomal physiological function of the intestine and the immune function of the body. It has been found that the disorder of intestinal microbiota is associated with numerous intestinal and parenteral diseases. Recently, the relationship between immune response and intestinal microbiota has been claimed. In a previous study using IMT to treat HBeAg positive chronic hepatits B patients combined with antiviral theraopy, 80% of them has reached HBeAg clearance. Increasing evidence suggests that the gut microbiota has evolved as a new important player in the pathogenesis of hepatitis B virus-induced chronic liver disease. However, the composition and structure alteration of the gut microbiota associated with the stage and progression of HBV infection remains unknown. Hence, we proposed a trial to detected gut microbiota of chronic HBV infected patients high-throughput 16S rRNA gene sequencing to elucidate the microbial influence which contribute to the microbial shift of patient in different stage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

chronic hepatitis b virus infected

Description

Inclusion Criteria:

  1. Alcohol free history or alcohol consumption <140g per week in male, <70g per week in female
  2. smooth and soft stool like sausage or snake
  3. Voluntary participate in this study

Exclusion Criteria:

  1. Syptom of digestive system disorder such as hematochezia, constipation, Abdominal distention, abdominal pain, diarrhea and jaundice within 1 month
  2. Abormal results of several tests including: fecal routine, fecal occult blood test
  3. Be diagnosed as enteritis within 1 month
  4. Chronic obstructive pulmonary disease, renal insufficiency and other systemic diseases.
  5. Autoimmune disease
  6. Chronic fatigue syndrome and neuropsychic disease
  7. A history of antibiotics, microecological preparation, gastrointestinal motility medicine, laxative, weight loss drug, Glucose lowering, blood fat regulation, glucocorticoid or immunosuppressor treatment within 1 month
  8. History of organic diseases in digestive system such as gastrointestinal polyposis, ulcers, malignancies, etc.
  9. History of gastrointestinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
health
  1. Alcohol free history or alcohol consumption <140g per week in male, <70g per week in female
  2. smooth and soft stool like sausage or snake
  3. Voluntary participate in this study
Other: collect fecal specimens
collect fresh fecal specimens of participants
chronic hepatitis b carrier
  1. Alcohol free history or alcohol consumption <140g per week in male, <70g per week in female
  2. Meet diagnostic criteria of chronic HBV infection in "EASL 2017 Clinical Practice Guidelines on the management"
Other: collect fecal specimens
collect fresh fecal specimens of participants
chronic hepatitis b
  1. Alcohol free history or alcohol consumption <140g per week in male, <70g per week in female
  2. Meet diagnostic criteria of chronic hepatitis B in "EASL 2017 Clinical Practice Guidelines on the management"
Other: collect fecal specimens
collect fresh fecal specimens of participants
decompensated cirrhosis
  1. Alcohol free history or alcohol consumption <140g per week in male, <70g per week in female
  2. Meet diagnostic criteria of chronic hepatitis B in "EASL 2017 Clinical Practice Guidelines on the management"
Other: collect fecal specimens
collect fresh fecal specimens of participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota
Time Frame: 1day
detected gut microbiota of participants through high-throughput 16S rRNA gene sequencing to elucidate the microbial influence which contribute to the microbial shift of patient in different stage.
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Hospital Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018001 (Sun Yat-Sen University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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