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

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ClinicalTrials.gov Identifier: NCT02953600
Recruitment Status : Unknown
Verified October 2016 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : November 3, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

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.

Condition or disease Intervention/treatment Phase
HBV Carrier Dietary Supplement: Standard Dose Spirulina Platensis Other: Zero Spirulina Platensis Dietary Supplement: Double Dose Spirulina Platensis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
Study Start Date : November 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Dose Spirulina Platensis
Spirulina platensis pill/500mg, 3 pills before each meal /6 pills per day
Dietary Supplement: Standard Dose Spirulina Platensis
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.

Active Comparator: Zero Spirulina Platensis
Spirulina platensis pill/500mg, 6 pills before each meal /12 pills per day
Dietary Supplement: Double Dose Spirulina Platensis
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.

Active Comparator: Double Dose Spirulina Platensis
same as usual, non pill taken
Other: Zero Spirulina Platensis
the zero pill-taken group is a comparison for two other groups.




Primary Outcome Measures :
  1. HBsAg(quantitative) [ Time Frame: treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same. ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02953600


Contacts
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Contact: Ming Shun Wu, Dr 886229307930 ext 7923 mswu@tmu.edu.tw

Locations
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Taiwan
WanFangH Recruiting
Tainan, Taiwan
Contact: Shu-Ching Chung    +886229307930 ext 7923    104494@w.tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Study Director: Ming Shun Wu, Dr WanFangHospital

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Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT02953600     History of Changes
Other Study ID Numbers: N201608026
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human