Clinical trial NCT03437876: Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis
Official title: A Randomised Study on Intestinal Microbiota Transplantation for Hepatitis B Virus Induced Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis, Liver
Keywords: HBV induced cirrhosis
intestinal microbiota transplantation
microbiota
Lead sponsor: Zhongshan Hospital Xiamen University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a open-label, self-control study
Primary purpose: TREATMENT

Brief summary: 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. 3%-5% compensatory liver cirrhosis develop to decompensated cirrhosis and suffer from series symptoms such as fatigue, edema, portal hypertension, splenomegaly, hemorrhage, hepatic encephalopathy, hepatorenal syndrome and so on. Chronic hepatitis B is closely related to the imbalance of intestinal microbiota, and the intestinal microbiota of patients is significantly different from healthy people. The response of patients to hepatitis B virus can be influenced by reconstructing intestinal flora, while Intestinal microbiota transplantation(IMT) is a significant method to achieve it. 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 randomized trial of IMT in patients with HBV induced cirrhosis. Patients will be randomized to either control group or IMT group over a 12 months period.

Detailed description: A group of 60 patients with HBV induced cirrhosis will be recruited for study, which involved a 4 times IMT with gastroduodenoscopy and the time interval is generally 2 weeks. Participants can keep taking their present treatment. All participants will be assessed at baseline, after 3 months, 6 months, 12 months from baseline in order to evaluate the possible changes in:

(1)Imaging changes: Color Doppler ultrasound of portal vein, CT/MRI, Fibroscan score of liver fibrosis and steatosis, Grading of varicosity under gastroscopy(GI); (2)Basic information and symptoms; (3)Biochemical indexes: Liver function, four items of liver fiber, lipid metabolism, blood routine, coagulation function, blood ammonia, inflammation, oxidative stress, urine routine; sugar metabolism indicators (blood glucose, glycosylated hemoglobin, insulin level and insulin resistance level).

(4) Changes of gut microbiota: The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) on baseline, 3 months, 6 months and 12 months after treatment samples to assess changes associated with IMT.

Eligibility criteria: 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

Primary outcomes:
measure: change of liver Fibroscan score
timeFrame: 3 months, 6 months, 12months
Secondary outcomes:
measure: Symptoms
timeFrame: 3 months, 6 months, 12months
measure: Changes of gut microbiota
timeFrame: 3 months, 6 months, 12months
measure: Color Doppler ultrasound of portal vein
timeFrame: 3 months, 6 months, 12months
measure: CT
timeFrame: 3 months, 6 months, 12months
measure: MRI
timeFrame: 3 months, 6 months, 12months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
state: Fujian
Study officials:
References: