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

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ClinicalTrials.gov Identifier: NCT03587467
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Zhongshan Hospital Xiamen University

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Hepatitis B Infection Healthy Other: collect fecal specimens

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study on Gut Microbiota in Chronic Hepatitis B Virus Infected Patients
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
chronic hepatitis b virus infected
Criteria

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

Information from the National Library of Medicine

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): NCT03587467


Locations
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China, Fujian
Zhongshan Hospital Affiliated to Xiamen University Recruiting
Xiamen, Fujian, China, 361000
Contact: Hongzhi Xu    +8613606000360    xuhongzhi07@163.com   
Contact: Yurou Xie    +8618559620899    350951378@qq.com   
Sponsors and Collaborators
Zhongshan Hospital Xiamen University

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Responsible Party: Zhongshan Hospital Xiamen University
ClinicalTrials.gov Identifier: NCT03587467     History of Changes
Other Study ID Numbers: 2018001
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections