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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03437876
Recruitment Status : Unknown
Verified October 2017 by Zhongshan Hospital Xiamen University.
Recruitment status was:  Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Zhongshan Hospital Xiamen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Other: intestinal microbiota transplant Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: a open-label, self-control study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Study on Intestinal Microbiota Transplantation for Hepatitis B Virus Induced Cirrhosis
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: patients with HBV induced cirrhosis
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
All participants take 4 times IMT by gastroduodenoscopy with 2-week intervals


Outcome Measures
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Primary Outcome Measures :
  1. change of liver Fibroscan score [ Time Frame: 3 months, 6 months, 12months ]
    Fibroscan score of liver fibrosis and steatosis


Secondary Outcome Measures :
  1. Symptoms [ Time Frame: 3 months, 6 months, 12months ]
    The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".

  2. Changes of gut microbiota [ Time Frame: 3 months, 6 months, 12months ]
    The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) in fecal samples from recruited patients.

  3. Color Doppler ultrasound of portal vein [ Time Frame: 3 months, 6 months, 12months ]
    Doppler ultrasonography is medical ultrasonography that employs the Doppler effect to generate imaging of the movement of tissues and body fluids (usually blood), and their relative velocity to the probe. By calculating the frequency shift of a particular sample volume, for example flow in an artery or a jet of blood flow over a heart valve, its speed and direction can be determined and visualized. Color Doppler is the presentation of the velocity by color scale. Color Doppler images are generally combined with grayscale (B-mode) images to display duplex ultrasonography images, allowing for simultaneous visualization of the anatomy of the area. This is particularly useful in cardiovascular studies (sonography of the vascular system and heart) and essential in many areas such as determining reverse blood flow in the liver vasculature in portal hypertension.

  4. CT [ Time Frame: 3 months, 6 months, 12months ]
    A CT scan, also known as computed tomography scan, makes use of computer-processed combinations of many X-ray measurements taken from different angles to produce cross-sectional (tomographic) images (virtual "slices") of specific areas of a scanned object, allowing the user to see inside the object without cutting. Other terms include computed axial tomography (CAT scan) and computer aided tomography.

  5. MRI [ Time Frame: 3 months, 6 months, 12months ]
    Hepatobiliary MR is used to detect and characterize lesions of the liver, pancreas, and bile ducts. Focal or diffuse disorders of the liver may be evaluated using diffusion-weighted, opposed-phase imaging, and dynamic contrast enhancement sequences. Extracellular contrast agents are used widely in liver MRI and newer hepatobiliary contrast agents also provide the opportunity to perform functional biliary imaging.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437876


Contacts
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Contact: Meiya Chen +8618950107602 meiya_chen@126.com
Contact: Yurou Xie +8618559620899 350951378@qq.com

Locations
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China, Fujian
Zhongshan Hospital Affiliated to Xiamen University Recruiting
Xiamen, Fujian, China, 361000
Contact: Meiya Chen    +8618950107602    meiya_chen@126.com   
Contact: Yurou Xie    +8618559620899    350951378@qq.com   
Sponsors and Collaborators
Zhongshan Hospital Xiamen University
  Study Documents (Full-Text)

Documents provided by Zhongshan Hospital Xiamen University:
Informed Consent Form  [PDF] June 28, 2017
Study Protocol  [PDF] June 28, 2017

More Information
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Responsible Party: Zhongshan Hospital Xiamen University
ClinicalTrials.gov Identifier: NCT03437876    
Other Study ID Numbers: 2017002
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongshan Hospital Xiamen University:
HBV induced cirrhosis
intestinal microbiota transplantation
microbiota
Additional relevant MeSH terms:
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Hepatitis B
Liver Cirrhosis
Fibrosis
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
 Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Pathologic Processes