Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration

Taipei Medical University

Status: Unknown

Conditions: HBV Carrier

Treatments: Dietary Supplement: Standard Dose Spirulina Platensis; Dietary Supplement: Double Dose Spirulina Platensis; Other: Zero Spirulina Platensis

Study type: Interventional

Funder types: Other

Identifiers

NCT02953600

N201608026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Standard Dose Spirulina Platensis

Experimental group

Description:

Spirulina platensis pill/500mg, 3 pills before each meal /6 pills per day

Treatment:

Dietary Supplement: Standard Dose Spirulina Platensis

Zero Spirulina Platensis

Active Comparator group

Description:

Spirulina platensis pill/500mg, 6 pills before each meal /12 pills per day

Treatment:

Dietary Supplement: Double Dose Spirulina Platensis

Double Dose Spirulina Platensis

Active Comparator group

Description:

same as usual, non pill taken

Treatment:

Other: Zero Spirulina Platensis