Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B (CHB)

February 5, 2018 updated by: Zhongshan Hospital Xiamen University

A Randomised Study on Intestinal Microbiota Transplantation for Chronic Hepatitis B Combined With Antiviral Therapy

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. Age is the main factor affecting the chronicity of hepatitis B, while 90% and 25% to 30% of hepatitis b virus(HBV) infection in perinatal and infant period will develop into chronic infection respectively. Whereas the proportion in patients above 5 years old is only 5% to 10%. Intestinal microbiota plays an important role in maintaining normal physiological function of the intestine and the immune function of the body. It has been found that the disorder of intestinal microbiota is associated with numerous intestinal and parenteral diseases. Intestinal microbiota transplantation(IMT) is a significant method to reconstruct intestinal flora. Recently, the relationship between immune response and intestinal microbiota has been claimed. 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 randomised trial of IMT in patients with chronic hepatitis B combined with antiviral therapy. The investigators will assess the serum HBsAg, anti-HBs, HBeAg, anti-HBe, anti-hepatitis B core antigen, the relief of gastrointestinal symptoms, and the fecal microbiota before and after IMT. Patients will be randomized to either antiviral therapy or IMT combined antiviral therapy over a 26 weeks period.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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. All participants will keep their present antiviral therapy. All participants will be assessed at baseline, after 1 months, 3 months, 6 months from baseline in order to evaluate the possible changes in:(1)Decrease of serum hepatitis B virus surface antigen(HBsAg) levels(as measured in IU/mL) and hepatitis B virus e antigen(HBeAg) levels(as measured in S/CO); (2)Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) and anti-hepatitis B virus e antigen(anti-HBe); (3)Relief of gastrointestinal symptoms:The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms"; (4)Changes of gut microbiota: The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) in fecal samples from recruited patients before and after IMT.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT Combined with Antiviral Therapy

60 chronic hepatitis B patients ongoing antiviral therapy will be recruited for the study, which involved a 6 times intestinal microbiota transplant and the time interval is generally 2 weeks.

Interventions:

Procedure: Intestinal Microbiota Transplantation Procedure: antiviral therapy
Other: intestinal microbiota transplant
Participants in experimental group take 6 times IMT with 2-week intervals.
Drug: Antiviral Agents
All participants continue present antiviral therapy over 12 months.
Other: Antiviral Agents

60 chronic hepatitis B patients ongoing antiviral therapy will be recruited for the study, which involved 12 months antiviral therapy.

Interventions:

Procedure: antiviral therapy
Drug: Antiviral Agents
All participants continue present antiviral therapy over 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum hepatitis B virus e antigen(HBeAg) level
Time Frame: 1 month, 3 months, 6months
Serum hepatitis B virus e antigen(HBeAg) levels is measured in S/CO
1 month, 3 months, 6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum hepatitis B virus surface antigen(HBsAg) level
Time Frame: 1 month, 3 months, 6months
Serum hepatitis B virus surface antigen(HBsAg) levels is measured in IU/mL .
1 month, 3 months, 6months
Change of serum anti-hepatitis B virus e antigen(anti-HBe)
Time Frame: 1 month, 3 months, 6months
Appearance of serum anti-hepatitis B virus e antigen(anti-HBe) suggest the ability of body to resistant HBV.
1 month, 3 months, 6months
Change of serum anti-hepatitis B virus surface antigen(anti-HBs)
Time Frame: 1 month, 3 months, 6months
Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) suggest the ability of body to resistant HBV.
1 month, 3 months, 6months
Changes of gut microbiota
Time Frame: 1 month, 3 months, 6months
Alpha and Beta diversity of GI microbiota by High-throughput sequencing (16S rRNA) on baseline line and1 month, 3 months, 6months after treatment
1 month, 3 months, 6months
relief of constipation
Time Frame: 1 month, 3 months, 6months
The onset and duration of constipation will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
1 month, 3 months, 6months
relief of diarrhea
Time Frame: 1 month, 3 months, 6months
The onset and duration of diarrhea will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
1 month, 3 months, 6months
relief of abdominal pain
Time Frame: 1 month, 3 months, 6months
The onset and duration of abdominal pain will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
1 month, 3 months, 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Hospital Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2017

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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