Dig Dis Sci. 2020 Apr 11. doi: 10.1007/s10620-020-06246-x. [Epub ahead of print]
Fecal Microbiota Transplantation in Hepatitis B e Antigen-Positive Chronic Hepatitis B Patients: A Pilot Study.
Chauhan A1, Kumar R2, Sharma S1, Mahanta M1, Vayuuru SK1, Nayak B1, Kumar S1, Shalimar3.
Author information
1
Department of Gastroenterology and Human Nutrition Unit, All India Institute of Medical Sciences, Room No 127, 1st Floor, New Delhi, 110029, India.
2
Department of Gastroenterology, All India Institute of Medical Sciences, Patna, India.
3
Department of Gastroenterology and Human Nutrition Unit, All India Institute of Medical Sciences, Room No 127, 1st Floor, New Delhi, 110029, India. [email protected].
Abstract
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: