Study on Gut Microbiota in Chronic HBV Infected Patients

NCT03587467 | Unknown

• 1 other identifier: 2018001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B Infection; Healthy

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  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

Study Arms (4)

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

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

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

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

Interventions

collect fecal specimens OTHER

collect fresh fecal specimens of participants

chronic hepatitis b; chronic hepatitis b carrier; decompensated cirrhosis; health

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

chronic hepatitis b virus infected

You may qualify if:

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

You may not qualify if:

• Syptom of digestive system disorder such as hematochezia, constipation, Abdominal distention, abdominal pain, diarrhea and jaundice within 1 month
• Abormal results of several tests including: fecal routine, fecal occult blood test
• Be diagnosed as enteritis within 1 month
• Chronic obstructive pulmonary disease, renal insufficiency and other systemic diseases.
• Autoimmune disease
• Chronic fatigue syndrome and neuropsychic disease
• 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
• History of organic diseases in digestive system such as gastrointestinal polyposis, ulcers, malignancies, etc.
• History of gastrointestinal surgery

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: December 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 16, 2018

Record last verified: 2018-07

Locations

CN (1)