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

Primary Purpose

Chronic Hepatitis b

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intestinal microbiota transplant
Antiviral Agents
Sponsored by
Zhongshan Hospital Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b focused on measuring chronic hepatitis B, intestinal microbiota transplantation, microbiota, antiviral therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Hospital Affiliated to Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IMT Combined with Antiviral Therapy

Antiviral Agents

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of serum hepatitis B virus e antigen(HBeAg) level
Serum hepatitis B virus e antigen(HBeAg) levels is measured in S/CO

Secondary Outcome Measures

Change of serum hepatitis B virus surface antigen(HBsAg) level
Serum hepatitis B virus surface antigen(HBsAg) levels is measured in IU/mL .
Change of serum anti-hepatitis B virus e antigen(anti-HBe)
Appearance of serum anti-hepatitis B virus e antigen(anti-HBe) suggest the ability of body to resistant HBV.
Change of serum anti-hepatitis B virus surface antigen(anti-HBs)
Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) suggest the ability of body to resistant HBV.
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
relief of constipation
The onset and duration of constipation will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
relief of diarrhea
The onset and duration of diarrhea will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
relief of abdominal pain
The onset and duration of abdominal pain will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".

Full Information

First Posted
October 24, 2017
Last Updated
February 5, 2018
Sponsor
Zhongshan Hospital Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT03429439
Brief Title
Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B
Acronym
CHB
Official Title
A Randomised Study on Intestinal Microbiota Transplantation for Chronic Hepatitis B Combined With Antiviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 29, 2017 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Hospital Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
chronic hepatitis B, intestinal microbiota transplantation, microbiota, antiviral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
an open label, parallel study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMT Combined with Antiviral Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Antiviral Agents
Arm Type
Other
Arm Description
60 chronic hepatitis B patients ongoing antiviral therapy will be recruited for the study, which involved 12 months antiviral therapy. Interventions: Procedure: antiviral therapy
Intervention Type
Other
Intervention Name(s)
intestinal microbiota transplant
Intervention Description
Participants in experimental group take 6 times IMT with 2-week intervals.
Intervention Type
Drug
Intervention Name(s)
Antiviral Agents
Intervention Description
All participants continue present antiviral therapy over 12 months.
Primary Outcome Measure Information:
Title
Change of serum hepatitis B virus e antigen(HBeAg) level
Description
Serum hepatitis B virus e antigen(HBeAg) levels is measured in S/CO
Time Frame
1 month, 3 months, 6months
Secondary Outcome Measure Information:
Title
Change of serum hepatitis B virus surface antigen(HBsAg) level
Description
Serum hepatitis B virus surface antigen(HBsAg) levels is measured in IU/mL .
Time Frame
1 month, 3 months, 6months
Title
Change of serum anti-hepatitis B virus e antigen(anti-HBe)
Description
Appearance of serum anti-hepatitis B virus e antigen(anti-HBe) suggest the ability of body to resistant HBV.
Time Frame
1 month, 3 months, 6months
Title
Change of serum anti-hepatitis B virus surface antigen(anti-HBs)
Description
Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) suggest the ability of body to resistant HBV.
Time Frame
1 month, 3 months, 6months
Title
Changes of gut microbiota
Description
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
Title
relief of constipation
Description
The onset and duration of constipation will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Time Frame
1 month, 3 months, 6months
Title
relief of diarrhea
Description
The onset and duration of diarrhea will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Time Frame
1 month, 3 months, 6months
Title
relief of abdominal pain
Description
The onset and duration of abdominal pain will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Time Frame
1 month, 3 months, 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Zhou
Phone
+8615396227038
Email
feiflyfei888@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yurou Xie
Phone
+8618559620899
Email
350951378@qq.com
Facility Information:
Facility Name
Zhongshan Hospital Affiliated to Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Zhou
Phone
+8615396227038
Email
feiflyfei888@163.com
First Name & Middle Initial & Last Name & Degree
Yurou Xie
Phone
+8618559620899
Email
350951378@qq.com

12. IPD Sharing Statement

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Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B

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