NCT03429439

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 29, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

February 12, 2018

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

October 24, 2017

Last Update Submit

February 5, 2018

Conditions

Chronic Hepatitis b

Keywords

chronic hepatitis Bintestinal microbiota transplantationmicrobiotaantiviral therapy

Outcome Measures

Primary Outcomes (1)

  • Change of serum hepatitis B virus e antigen(HBeAg) level

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

    1 month, 3 months, 6months

Secondary Outcomes (7)

  • Change of serum hepatitis B virus surface antigen(HBsAg) level

    1 month, 3 months, 6months

  • Change of serum anti-hepatitis B virus e antigen(anti-HBe)

    1 month, 3 months, 6months

  • Change of serum anti-hepatitis B virus surface antigen(anti-HBs)

    1 month, 3 months, 6months

  • Changes of gut microbiota

    1 month, 3 months, 6months

  • relief of constipation

    1 month, 3 months, 6months

  • +2 more secondary outcomes

Study Arms (2)

IMT Combined with Antiviral Therapy

EXPERIMENTAL

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 transplantDrug: Antiviral Agents

Antiviral Agents

OTHER

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

Interventions

intestinal microbiota transplantOTHER

Participants in experimental group take 6 times IMT with 2-week intervals.

IMT Combined with Antiviral Therapy
Antiviral AgentsDRUG

All participants continue present antiviral therapy over 12 months.

Antiviral AgentsIMT Combined with Antiviral Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent/assent as appropriate
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Fecal Microbiota TransplantationAntiviral Agents

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Fei Zhou

CONTACT

+8615396227038feiflyfei888@163.com

Yurou Xie

CONTACT

+8618559620899350951378@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: an open label, parallel study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

February 12, 2018

Study Start

December 29, 2017

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

February 12, 2018

Record last verified: 2017-10

Locations

CN(1)