Study on Gut Microbiota in Chronic HBV Infected Patients

NCT ID: NCT03587467

Last Updated: 2018-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis B Infection Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

collect fecal specimens

Intervention Type OTHER

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"

collect fecal specimens

Intervention Type OTHER

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"

collect fecal specimens

Intervention Type OTHER

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"

collect fecal specimens

Intervention Type OTHER

collect fresh fecal specimens of participants

Interventions

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collect fecal specimens

collect fresh fecal specimens of participants

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Hospital Xiamen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Hongzhi Xu

Role: primary

+8613606000360

Yurou Xie

Role: backup

+8618559620899

Other Identifiers

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2018001

Identifier Type: -

Identifier Source: org_study_id

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