Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B
Status:
Unknown status
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
Summary
Chronic hepatitis B(CHB) 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 normal 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. Intestinal microbiota
transplantation(IMT) is a significant method to reconstruct intestinal flora. Recently, the
relationship between immune response and intestinal microbiota has been claimed. In a
previous study using IMT to treat HBeAg positive chronic hepatitis B patients combined with
antiviral therapy, 80% of them has reached HBeAg clearance. The investigators propose a
randomised trial of IMT in patients with chronic hepatitis B combined with antiviral therapy.
The investigators will assess the serum HBsAg, anti-HBs, HBeAg, anti-HBe, anti-hepatitis B
core antigen, the relief of gastrointestinal symptoms, and the fecal microbiota before and
after IMT. Patients will be randomized to either antiviral therapy or IMT combined antiviral
therapy over a 26 weeks period.