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Trial record 9 of 324 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03429439
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Zhongshan Hospital Xiamen University

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.

Condition or disease Intervention/treatment
Chronic Hepatitis b Other: intestinal microbiota transplant Drug: Antiviral Agents

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: an open label, parallel study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Study on Intestinal Microbiota Transplantation for Chronic Hepatitis B Combined With Antiviral Therapy
Actual Study Start Date : December 29, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: IMT Combined with Antiviral Therapy

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 transplant
Participants in experimental group take 6 times IMT with 2-week intervals.
Drug: Antiviral Agents
All participants continue present antiviral therapy over 12 months.
Antiviral Agents

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
All participants continue present antiviral therapy over 12 months.



Primary Outcome Measures :
  1. Change of serum hepatitis B virus e antigen(HBeAg) level [ Time Frame: 1 month, 3 months, 6months ]
    Serum hepatitis B virus e antigen(HBeAg) levels is measured in S/CO


Secondary Outcome Measures :
  1. Change of serum hepatitis B virus surface antigen(HBsAg) level [ Time Frame: 1 month, 3 months, 6months ]
    Serum hepatitis B virus surface antigen(HBsAg) levels is measured in IU/mL .

  2. Change of serum anti-hepatitis B virus e antigen(anti-HBe) [ Time Frame: 1 month, 3 months, 6months ]
    Appearance of serum anti-hepatitis B virus e antigen(anti-HBe) suggest the ability of body to resistant HBV.

  3. Change of serum anti-hepatitis B virus surface antigen(anti-HBs) [ Time Frame: 1 month, 3 months, 6months ]
    Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) suggest the ability of body to resistant HBV.

  4. Changes of gut microbiota [ Time Frame: 1 month, 3 months, 6months ]
    Alpha and Beta diversity of GI microbiota by High-throughput sequencing (16S rRNA) on baseline line and1 month, 3 months, 6months after treatment

  5. relief of constipation [ Time Frame: 1 month, 3 months, 6months ]
    The onset and duration of constipation will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".

  6. relief of diarrhea [ Time Frame: 1 month, 3 months, 6months ]
    The onset and duration of diarrhea will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".

  7. relief of abdominal pain [ Time Frame: 1 month, 3 months, 6months ]
    The onset and duration of abdominal pain will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03429439


Contacts
Contact: Fei Zhou +8615396227038 feiflyfei888@163.com
Contact: Yurou Xie +8618559620899 350951378@qq.com

Locations
China, Fujian
Zhongshan Hospital Affiliated to Xiamen University Recruiting
Xiamen, Fujian, China, 361000
Contact: Fei Zhou    +8615396227038    feiflyfei888@163.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:
Study Protocol  [PDF] February 5, 2018
Informed Consent Form  [PDF] February 5, 2018


Responsible Party: Zhongshan Hospital Xiamen University
ClinicalTrials.gov Identifier: NCT03429439     History of Changes
Other Study ID Numbers: 2017003
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: October 2017

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:
chronic hepatitis B
intestinal microbiota transplantation
microbiota
antiviral therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents