Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis

Xiamen University logo

Xiamen University

Status

Unknown

Conditions

Cirrhosis, Liver

Treatments

Other: intestinal microbiota transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT03437876
2017002

Details and patient eligibility

About

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.

Full description

A group of 60 patients with HBV induced cirrhosis will be recruited for study, which involved a 4 times IMT with gastroduodenoscopy and the time interval is generally 2 weeks. Participants can keep taking their present treatment. All participants will be assessed at baseline, after 3 months, 6 months, 12 months from baseline in order to evaluate the possible changes in: (1)Imaging changes: Color Doppler ultrasound of portal vein, CT/MRI, Fibroscan score of liver fibrosis and steatosis, Grading of varicosity under gastroscopy(GI); (2)Basic information and symptoms; (3)Biochemical indexes: Liver function, four items of liver fiber, lipid metabolism, blood routine, coagulation function, blood ammonia, inflammation, oxidative stress, urine routine; sugar metabolism indicators (blood glucose, glycosylated hemoglobin, insulin level and insulin resistance level). (4) Changes of gut microbiota: The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) on baseline, 3 months, 6 months and 12 months after treatment samples to assess changes associated with IMT.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

patients with HBV induced cirrhosis
Experimental group
Description:
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.
Treatment:
Other: intestinal microbiota transplant

Trial documents
2

Trial contacts and locations

1

Loading...

Central trial contact

Meiya Chen; Yurou Xie

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems