A Randomised Study on Intestinal Microbiota Transplantation for Hepatitis B Virus Induced Cirrhosis
Phase: NA
Conditions: Cirrhosis, Liver
Sponsor: Zhongshan Hospital Xiamen University

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

Study on Effect of Intestinal Microbiota
Transplantation in Hepatitis B Virus Induced Cirrhosis
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, able to keep treatment
• 18 to 50 years of age
• Chronic hepatitis B, definitely diagnosed as hepatic fibrosis/cirrhosis
through Fibroscan/Biopsy of liver biopsy
Exclusion Criteria:
• Drug treatment(immunosuppressive drugs, biological agents, high dose
vitamins or other immunosuppressive drugs
• Other immune related diseases
• Gastrointestinal organic lesions such as gastroesophageal reflux disease,
inflammatory bowel disease, intestinal tumor
• 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:
patients
with
HBV
induced cirrhosis
patients with HBV induced cirrhosis
will
be
recruited
for
sutdy,
which
involved a 4 times intestinal microbiota
transplant
and
the
time
interval
is
generally 2 weeks
intestinal microbiota transplant
All participants take 4 times IMT by
gastroduodenoscopy with 2-week intervals
3)Outcome Measures
Primary Outcome Measure:
1
Fibroscan score of liver fibrosis and steatosis
[Time Frame: 3 months, 6 months, 12months]
Secondary Outcome Measure:
2
Symptoms
The onset and duration of gastrointestinal symptoms will be assessed by
"Evaluation Score Table of Gastrointestinal Symptoms".
[Time Frame: 3 months, 6 months, 12months]
3
Color Doppler ultrasound of portal vein
[Time Frame: 3 months, 6 months, 12months]
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]
5
CT/MRI
[Time Frame: 3 months, 6 months, 12months]