Fecal Microbiota Transplantation in Hepatitis B e Antigen-Positive Chronic Hepatitis B Patients: A Pilot Study

Dig Dis Sci. 2021 Mar;66(3):873-880. doi: 10.1007/s10620-020-06246-x. Epub 2020 Apr 11.


Background: Intestinal flora plays a critical role in immunity against hepatitis B virus (HBV). Fecal Microbiota Transplantation (FMT) may be a potential immunomodulatory therapy in patients with chronic hepatitis B (CHB).

Aim: We aimed to study role of FMT in hepatitis B e antigen (HBeAg)-positive CHB patients in terms of its effect on HBeAg, HBsAg, and HBV DNA.

Methods: HBeAg-positive patients despite being on antiviral treatment for > 1 year were given six cycles of FMT via gastroscope (nasoduodenal route) at 4 weekly intervals along with antiviral therapy. Twelve out of 14 included patients in FMT arm completed six cycles. Another 15 HBeAg-positive patients who were on oral antivirals for > 1 year were taken as control-antiviral therapy (AVT) arm. Per-protocol analysis was done.

Results: The median (interquartile range) age in the FMT and AVT arm were 29 (25-35) and 29(24-38), respectively (P = 0.794). The median (interquartile range) duration of AVT prior to inclusion in the study was 80 (52-104) and 76 (52-114) months in FMT and AVT arm, respectively (P = 0.884). In the FMT arm, 16.7% (2/12) patients had HBeAg clearance in comparison to none in the AVT arm (P = 0.188). None of the patients in either arm had HBsAg loss. The FMT was tolerated well, 42.8% (6/14) patients reported one or more minor adverse events.

Conclusions: In this non-randomized pilot study, FMT appears to be safe and potentially effective in terms of viral suppression and HBeAg clearance in patients with HBeAg-positive CHB. Further randomized controlled trials are needed in order to obtain robust conclusions.

Keywords: Bacteria; Dysbiosis; Fungi; Microbiome; Virus.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Antiviral Agents / therapeutic use
  • DNA, Viral / blood
  • DNA, Viral / immunology
  • Fecal Microbiota Transplantation / methods*
  • Female
  • Hepatitis B Surface Antigens / blood
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B e Antigens / blood*
  • Hepatitis B e Antigens / immunology
  • Hepatitis B virus / immunology*
  • Hepatitis B, Chronic / blood
  • Hepatitis B, Chronic / therapy*
  • Hepatitis B, Chronic / virology
  • Humans
  • Male
  • Pilot Projects
  • Treatment Outcome
  • Young Adult


  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens