A Randomised Study on Intestinal Microbiota Transplantation for Chronic Hepatitis B Combined With Antiviral Therapy
Phase: NA
Conditions: Chronic Hepatitis b
Sponsor: Zhongshan Hospital Xiamen University

Study on Effect of Intestinal
Microbiota Transplantation in
Chronic Hepatitis B
Date：2017-06-28

1.Method
Intestinal microbiota transplantation(IMT) refers to make fecal from the health
into a suspension of microbes through an intelligent bacteria processing system,
and then infuse the suspension into the gastrointestinal tract of patients through
naso intestinal tube, gastroscope, enteroscope or capsule intake which can
reconstruct intestinal microbiota and play the role of treatment without obvious
side effect.
2.Plan
1)Patient recruitment
Inclusion Criteria:
• Written informed consent/assent as appropriate
• 18 to 65 years of age
• No alcohol consumption or alcohol consumption <140g per week in men,
and <70g per ween in women
• Been diagnosed with chronic hepatitis B
Exclusion Criteria:
• Alcoholic liver disease (ALD), chronic hepatitis C, autoimmune liver
disease, Wilson's disease
• Drug treatment (tamoxifen, amiodarone, sodium valproate, methotrexate,
glucocorticoids, etc.), total parenteral nutrition, inflammatory bowel
disease, hypothyroidism, Cushing's syndrome, beta lipoprotein deficiency,
IR related syndromes (lipid wasting diabetes mellitus, Mauriac syndrome),
gastrointestinal surgery
• Hepatocellular carcinoma (HCC), biliary tract diseases and taking or taking
chinese and western medicines that can lead liver enzymes elevation in
the near future.
• Moderate and severe renal injuty(serum creatinine>2mg/dL or 177mmol/
L), moderate and severe chronic obstructive pulmonary disease, severe
hypertension, cerebrovascular accident, congestive heart failure, unstable
angina pectoris.

• Antibiotics treatment in 7 days before recruited and unwilling to stop it,
long-term lipid-lowering drugs, antidiabetic drugs and other liver protecting
drugs treatment
• Antibiotics, other probiotics, gastrointestinal motility drugs and other
preparation that may influence intestinal microbiota treatment
• Other serious diseases that may interfere the recruitment or affect the
survival, such as cancer or acquired immune deficiency syndrome
• Mentally or legally disabled person
• Preparing for pregnancy
• Medical or social condition which in the opinion of the principal investigator
would interfere with or prevent regular follow up
• Participating in other clinical trials.
Recuit the patients who meet the inclusion criteria, and fail to meet the
exclusion criteria. Introduce this clinical trial to the patients and obtain the
informed consent. Assess the condition of the disease.
2)Arms and Interventions
Randomly divided the patients into experimental arm and control arm and
intervene them as described in the following table.
arms
Assigned interventions
Experimental:
IMT
Combined
with
Antiviral Therapy
60
chronic
hepatitis
B
patients
ongoing
antiviral
theraoy
will
be
recruited for the sutdy, which involved
a
6
times
intestinal
microbiota
transplant
and
the
time
interval
is
generally 2 weeks.
Interventions:
Procedure:
Intestinal
Microbiota
intestinal microbiota transplant
Participants in Exprerimental group
take 6 times IMT with 2-week intervals.
Drug: Antiviral Agents
All participants continue present
antiviral therapy over 12 months.

Transplantation
Procedure: antiviral therapy
Antiviral Agents
60
chronic
hepatitis
B
patients
ongoing
antiviral
theraoy
will
be
recruited for the sutdy, which involved
12 months antiviral therapy.
Interventions:
Procedure: antiviral therapy
Drug: Antiviral Agents
All participants continue present
antiviral therapy over 12 months.
3)Outcome Measures
Primary Outcome Measure:
1
Decrease of serum hepatitis B virus surface antigen(HBsAg) levels and
hepatitis B virus e antigen(HBeAg) levels
Serum hepatitis B virus surface antigen(HBsAg) levels is measured in IU/mL and
hepatitis B virus e antigen(HBeAg) levesl is measured in S/CO.
[Time Frame: 1 month, 3 months, 6months]
2
Appearance of serum anti-hepatiits B virus surface antigen(anti-HBs) and
anti-hepatiits B virus e antigen(anti-HBe)
Appearance of serum anti-hepatiits B virus surface antigen(anti-HBs) and
anti-hepatiits B virus e antigen(anti-HBe) suggest the ability of body to
resistant HBV.
[Time Frame: 1 month, 3 months, 6months]
Secondary Outcome Measure:
3
Relief of gastrointestinal symptoms
The onset and duration of gastrointestinal symptoms will be assessed by
“Evaluation Score Table of Gastrointestinal Symptoms”.
[Time Frame: 1 month, 3 months, 6months]
4
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]