NCT03437876

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.

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 Oct 2016

Longer than P75 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

Study Start

First participant enrolled

October 31, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 19, 2018

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

October 25, 2017

Last Update Submit

February 11, 2018

Conditions

Cirrhosis, Liver

Keywords

HBV induced cirrhosisintestinal microbiota transplantationmicrobiota

Outcome Measures

Primary Outcomes (1)

  • change of liver Fibroscan score

    Fibroscan score of liver fibrosis and steatosis

    3 months, 6 months, 12months

Secondary Outcomes (5)

  • Symptoms

    3 months, 6 months, 12months

  • Changes of gut microbiota

    3 months, 6 months, 12months

  • Color Doppler ultrasound of portal vein

    3 months, 6 months, 12months

  • CT

    3 months, 6 months, 12months

  • MRI

    3 months, 6 months, 12months

Study Arms (1)

patients with HBV induced cirrhosis

EXPERIMENTAL

patients with HBV induced cirrhosis will be recruited for study, which involved a 4 times intestinal microbiota transplant and the time interval is generally 2 weeks.

Other: intestinal microbiota transplant

Interventions

intestinal microbiota transplantOTHER

All participants take 4 times IMT by gastroduodenoscopy with 2-week intervals

patients with HBV induced cirrhosis

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent/assent as appropriate, able to keep treatment
  • to 50 years of age
  • Chronic hepatitis B, definitely diagnosed as hepatic fibrosis/cirrhosis through Fibroscan/Biopsy of liver biopsy

You may not qualify if:

  • 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

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

Liver Cirrhosis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Central Study Contacts

Meiya Chen

CONTACT

+8618950107602meiya_chen@126.com

Yurou Xie

CONTACT

+8618559620899350951378@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: a open-label, self-control study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

February 19, 2018

Study Start

October 31, 2016

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

February 19, 2018

Record last verified: 2017-10

Locations

CN(1)