Chronic Hepatitis bCHBNCT03429439
Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B
A study testing intestinal microbiota transplant and Antiviral Agents in people with Chronic Hepatitis b, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- intestinal microbiota transplant and Antiviral Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2017to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361000
Fei Zhou, +8615396227038, feiflyfei888@163.com
Yurou Xie, +8618559620899, 350951378@qq.com
About this study
Official title: A Randomised Study on Intestinal Microbiota Transplantation for Chronic Hepatitis B Combined With Antiviral Therapy
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.
Read the 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.
- Conditions
- Chronic Hepatitis b
- Being tested
- intestinal microbiota transplant, Antiviral Agents
- Keywords
- chronic hepatitis B, intestinal microbiota transplantation, microbiota, antiviral therapy
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intestinal microbiota transplantOther
Participants in experimental group take 6 times IMT with 2-week intervals.
Antiviral AgentsDrug
All participants continue present antiviral therapy over 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: intestinal microbiota transplant; Drug: 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 Receives: Drug: Antiviral Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum hepatitis B virus e antigen(HBeAg) level
Serum hepatitis B virus e antigen(HBeAg) levels is measured in S/CO
Measured: 1 month, 3 months, 6months
Secondary outcomes (7)
Change of serum hepatitis B virus surface antigen(HBsAg) level
Serum hepatitis B virus surface antigen(HBsAg) levels is measured in IU/mL .
Measured: 1 month, 3 months, 6months
Change of serum anti-hepatitis B virus e antigen(anti-HBe)
Appearance of serum anti-hepatitis B virus e antigen(anti-HBe) suggest the ability of body to resistant HBV.
Measured: 1 month, 3 months, 6months
Change of serum anti-hepatitis B virus surface antigen(anti-HBs)
Appearance of serum anti-hepatitis B virus surface antigen(anti-HBs) suggest the ability of body to resistant HBV.
Measured: 1 month, 3 months, 6months
Changes of gut microbiota
Alpha and Beta diversity of GI microbiota by High-throughput sequencing (16S rRNA) on baseline line and1 month, 3 months, 6months after treatment
Measured: 1 month, 3 months, 6months
relief of constipation
The onset and duration of constipation will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Measured: 1 month, 3 months, 6months
relief of diarrhea
The onset and duration of diarrhea will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Measured: 1 month, 3 months, 6months
relief of abdominal pain
The onset and duration of abdominal pain will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
Measured: 1 month, 3 months, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start29 Dec 2017
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an open label, parallel study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429439
- Sponsor's protocol ID
- 2017003
- Acronym
- CHB
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study on Intestinal Microbiota Transplantation for Chronic Hepatitis B Combined With Antiviral Therapy
- ClinicalTrials.gov ID
- NCT03429439
- Acronym / sponsor ID
- CHB / 2017003
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis B, intestinal microbiota transplantation, microbiota, antiviral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an open label, parallel study
| Arm | Type | Receives |
|---|---|---|
| IMT Combined with Antiviral Therapy | Experimental | Other: intestinal microbiota transplant, Drug: Antiviral Agents60 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 |
| Antiviral Agents | Other | Drug: Antiviral Agents60 chronic hepatitis B patients ongoing antiviral therapy will be recruited for the study, which involved 12 months antiviral therapy. Interventions: Procedure: antiviral therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intestinal microbiota transplantParticipants in experimental group take 6 times IMT with 2-week intervals. | Other | IMT Combined with Antiviral Therapy |
| Antiviral AgentsAll participants continue present antiviral therapy over 12 months. | Drug | Antiviral Agents, IMT Combined with Antiviral Therapy |
Primary outcome
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
7 secondary outcomes
Change of serum hepatitis B virus surface antigen(HBsAg) level
Time frame: 1 month, 3 months, 6months
Change of serum anti-hepatitis B virus e antigen(anti-HBe)
Time frame: 1 month, 3 months, 6months
Change of serum anti-hepatitis B virus surface antigen(anti-HBs)
Time frame: 1 month, 3 months, 6months
Changes of gut microbiota
Time frame: 1 month, 3 months, 6months
relief of constipation
Time frame: 1 month, 3 months, 6months
relief of diarrhea
Time frame: 1 month, 3 months, 6months
relief of abdominal pain
Time frame: 1 month, 3 months, 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intestinal microbiota transplant and Antiviral Agents in people with Chronic Hepatitis b, run by Zhongshan Hospital Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Zhou (+8615396227038, feiflyfei888@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum hepatitis B virus e antigen(HBeAg) level (time frame: 1 month, 3 months, 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.