HBV CarrierNCT02953600
Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
A study testing Standard Dose Spirulina Platensis, Zero Spirulina Platensis and Double Dose Spirulina Platensis in people with HBV Carrier, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HBV Carrier
- What is being tested?
- Standard Dose Spirulina Platensis, Zero Spirulina Platensis and Double Dose Spirulina Platensis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2016to Aug 2017
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In patients with chronic hepatitis B of taking oral antiviral drugs , and the virus has been detected is less than the amount (HBV DNA <20 IU / ml), aged between 20 years to 75 years .
Who cannot join
- Patients were allergic to seafood.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
WanFangH
Tainan
Shu-Ching Chung, +886229307930 ext. 7923, 104494@w.tmu.edu.tw
About this study
Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.
Read the detailed description
Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.
Spirulina platensis is a kind of ancient livings for a 3.5 billions years, and had been recognized as a kind of space food by National Aeronautics and Space Administration(USA) because of containing numerous nutrients, especially vitamin B and beta-carotene. Beta-carotene would convert into vitamin A and help keep health vision, skin, and mucosa. With a rich source of vitamins B, especial B12 which is almost only in meals (animal livers), 1.2 grams of Spirulina platensis daily uptake would be sufficient for a human daily need, and also be a very good source for vegetarians. The investigators add the B12 test in this trial as a secondary endpoint to help monitor the absorption rates of the Spirulina platensis in human. Otherwise, the plant pigments in Spirulina platensis would also have many bioactivities on human healthy. Among these bio-activities of Spirulina platensis would contain anti-virus, anti-cancer, immune modulation, anti-inflammation, anti-oxidant, improve liver abnormality, and liver cirrhosis abilities. As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg.
- Conditions
- HBV Carrier
- Being tested
- Standard Dose Spirulina Platensis, Zero Spirulina Platensis, Double Dose Spirulina Platensis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dose Spirulina PlatensisDietary supplement
As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg.
Zero Spirulina PlatensisOther
the zero pill-taken group is a comparison for two other groups.
Double Dose Spirulina PlatensisDietary supplement
As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg. Hence, the investigators would like to see if the investigators could improve sero-conversion rates much faster by taking double dose of Spirulina platensis.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dose Spirulina Platensis | Experimental | Spirulina platensis pill/500mg, 3 pills before each meal /6 pills per day Receives: Dietary Supplement: Standard Dose Spirulina Platensis |
| Zero Spirulina Platensis | Active comparator | Spirulina platensis pill/500mg, 6 pills before each meal /12 pills per day Receives: Dietary Supplement: Double Dose Spirulina Platensis |
| Double Dose Spirulina Platensis | Active comparator | same as usual, non pill taken Receives: Other: Zero Spirulina Platensis |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg(quantitative)
Measured: treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV CarrierStudies 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
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Shun Wu, Dr, Study director, WanFangHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953600
- Sponsor's protocol ID
- N201608026
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
- ClinicalTrials.gov ID
- NCT02953600
- Acronym / sponsor ID
- N201608026
- Conditions
- HBV Carrier
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 3 Nov 2016 (estimated)
- 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.
Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.
Detailed description
Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.
Spirulina platensis is a kind of ancient livings for a 3.5 billions years, and had been recognized as a kind of space food by National Aeronautics and Space Administration(USA) because of containing numerous nutrients, especially vitamin B and beta-carotene. Beta-carotene would convert into vitamin A and help keep health vision, skin, and mucosa. With a rich source of vitamins B, especial B12 which is almost only in meals (animal livers), 1.2 grams of Spirulina platensis daily uptake would be sufficient for a human daily need, and also be a very good source for vegetarians. The investigators add the B12 test in this trial as a secondary endpoint to help monitor the absorption rates of the Spirulina platensis in human. Otherwise, the plant pigments in Spirulina platensis would also have many bioactivities on human healthy. Among these bio-activities of Spirulina platensis would contain anti-virus, anti-cancer, immune modulation, anti-inflammation, anti-oxidant, improve liver abnormality, and liver cirrhosis abilities. As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Dose Spirulina Platensis | Experimental | Dietary Supplement: Standard Dose Spirulina PlatensisSpirulina platensis pill/500mg, 3 pills before each meal /6 pills per day |
| Zero Spirulina Platensis | Active comparator | Dietary Supplement: Double Dose Spirulina PlatensisSpirulina platensis pill/500mg, 6 pills before each meal /12 pills per day |
| Double Dose Spirulina Platensis | Active comparator | Other: Zero Spirulina Platensissame as usual, non pill taken |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In patients with chronic hepatitis B of taking oral antiviral drugs , and the virus has been detected is less than the amount (HBV DNA <20 IU / ml), aged between 20 years to 75 years .
Key exclusion criteria (1 listed)
- Patients were allergic to seafood.
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 |
|---|---|---|
| Standard Dose Spirulina PlatensisAs previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg. | Dietary supplement | Standard Dose Spirulina Platensis |
| Zero Spirulina Platensisthe zero pill-taken group is a comparison for two other groups. | Other | Double Dose Spirulina Platensis |
| Double Dose Spirulina PlatensisAs previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg. Hence, the investigators would like to see if the investigators could improve sero-conversion rates much faster by taking double dose of Spirulina platensis. | Dietary supplement | Zero Spirulina Platensis |
Primary outcome
HBsAg(quantitative)
Time frame: treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for HBV Carrier
RecruitingObservational study
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Hepatitis Delta With Hepatitis B Carrier State, Chronic Hepatitis b
RecruitingPhase 3
Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
Gastrointestinal Cancers
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.
Ming Shun Wu, Dr study director
WanFangHospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Dose Spirulina Platensis, Zero Spirulina Platensis and Double Dose Spirulina Platensis in people with HBV Carrier, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 11 Nov 2016. 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 Taiwan. 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 Ming Shun Wu, Dr (886229307930 ext. 7923, mswu@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg(quantitative) (time frame: treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.). 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 11 Nov 2016.