An interventional study of intestinal microbiota transplant and Antiviral Agents in Chronic Hepatitis b, sponsored by Zhongshan Hospital Xiamen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-12.
Sponsored by Zhongshan Hospital Xiamen University · Not applicable, Interventional, and Treatment
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.
A group of 60 chronic hepatitis B patients combined with antiviral therapy will be recruited for study, which involved a 6 times IMT with gastroduodenoscopy and the time interval is generally 2 weeks. All participants will keep their present antiviral therapy. All participants will be assessed at baseline, after 1 months, 3 months, 6 months from baseline in order to evaluate the possible changes in:(1)Decrease of serum hepatitis B virus surface antigen(HBsAg) levels(as measured in IU/mL) and hepatitis B virus e antigen(HBeAg) levels(as measured in S/CO); (2)Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) and anti-hepatitis B virus e antigen(anti-HBe); (3)Relief of gastrointestinal symptoms:The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms"; (4)Changes of gut microbiota: The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) in fecal samples from recruited patients before and after IMT.
Exclusion Criteria:
60 chronic hepatitis B patients ongoing antiviral therapy will be recruited for the study, which involved a 6 times intestinal microbiota transplant and the time interval is generally 2 weeks. Interventions: Procedure: Intestinal Microbiota Transplantation Procedure: antiviral therapy
Other: intestinal microbiota transplant · Drug: Antiviral Agents
60 chronic hepatitis B patients ongoing antiviral therapy will be recruited for the study, which involved 12 months antiviral therapy. Interventions: Procedure: antiviral therapy
Drug: Antiviral Agents
Participants in experimental group take 6 times IMT with 2-week intervals.
All participants continue present antiviral therapy over 12 months.
Change of serum hepatitis B virus e antigen(HBeAg) level
Serum hepatitis B virus e antigen(HBeAg) levels is measured in S/CO
Time frame: 1 month, 3 months, 6months
Change of serum hepatitis B virus surface antigen(HBsAg) level
Serum hepatitis B virus surface antigen(HBsAg) levels is measured in IU/mL .
Time frame: 1 month, 3 months, 6months
Change of serum anti-hepatitis B virus e antigen(anti-HBe)
Appearance of serum anti-hepatitis B virus e antigen(anti-HBe) suggest the ability of body to resistant HBV.
Time frame: 1 month, 3 months, 6months
Change of serum anti-hepatitis B virus surface antigen(anti-HBs)
Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) suggest the ability of body to resistant HBV.
Time frame: 1 month, 3 months, 6months
Changes of gut microbiota
Alpha and Beta diversity of GI microbiota by High-throughput sequencing (16S rRNA) on baseline line and1 month, 3 months, 6months after treatment
Time frame: 1 month, 3 months, 6months
relief of constipation
The onset and duration of constipation will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Time frame: 1 month, 3 months, 6months
relief of diarrhea
The onset and duration of diarrhea will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Time frame: 1 month, 3 months, 6months
relief of abdominal pain
The onset and duration of abdominal pain will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Time frame: 1 month, 3 months, 6months
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Zhongshan Hospital Xiamen University