Status:
UNKNOWN
Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B
Lead Sponsor:
Zhongshan Hospital Xiamen University
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
Phase:
NA
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 chron...
Detailed Description
A group of 60 chronic hepatitis B patients combined with antiviral therapy will be recruited for study, which involved a 6 times IMT with gastroduodenoscopy and the time interval is generally 2 weeks....
Eligibility Criteria
Inclusion
- 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
- 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, insulin resistance 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 injury(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.
Key Trial Info
Start Date :
December 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03429439
Start Date
December 29 2017
End Date
November 1 2020
Last Update
February 12 2018
Active Locations (1)
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1
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China, 361000