Clinical trial NCT02953600: Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
Official title: Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HBV Carrier
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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 .

Exclusion Criteria:

* Patients were allergic to seafood.

Primary outcomes:
measure: HBsAg(quantitative)
timeFrame: treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: WanFangH
Study officials:
affiliation: WanFangHospital
name: Ming Shun Wu, Dr
role: STUDY_DIRECTOR
References: