NCT04718831

Brief Summary

Hepatocellular carcinoma (HCC), listed among lung and breast cancers as the top-ten cancer in 2016 Taiwan, is the second most prevalent cancer, just one place below colon cancer. Due to mass hepatitis B vaccination and the screening and therapeutic plan against hepatitis B and C viruses (HBV and HCV, respectively), the incidence of liver cancer drops significantly, however, still around twenty out of per hundred thousand population die from liver cancer each year. For patients suffering HBV and HCV, the prevention of HCC is a crucial health issue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

January 20, 2021

Last Update Submit

January 20, 2021

Conditions

Chronic Hepatitis b

Keywords

SpirulinaAntigen

Outcome Measures

Primary Outcomes (1)

  • HBV DNA

    The change of HBV DNA during six months

    6 months

Study Arms (3)

Baseline

OTHER

Did not take nutritious food

Dietary Supplement: Spirulina

General dose

EXPERIMENTAL

Taking 6g spirulina

Dietary Supplement: Spirulina

Double dose

EXPERIMENTAL

Taking 12g spirulina

Dietary Supplement: Spirulina

Interventions

SpirulinaDIETARY_SUPPLEMENT

Spirulina, as demonstrated in previous researches in vitro and in animals, can regulate immunity, enhance anti-virus activity, lower inflammation response and slower tumor progression. Liver function and liver fibrosis is improved by Spirulina as well. In our recent clinical trial, hepatitis B patients that received anti-virus medicine orally and was supplemented with Spirulina FEM-102 showed lower qHBsAg, reflecting the clearance of cccDNA. It might be related to immune modulation against HBV, which is induced by Spirulina.

BaselineDouble doseGeneral dose

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic hepatitis B do not take oral antiviral drugs.
  • Ages between 20 and 75.
  • High concentration of qHBsAg. qHBsAg≧1000 IU/ mL

You may not qualify if:

  • People allergic to seefood.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wanfang Hospital

Taipei, Wenshan District, 116, Taiwan

Location

Related Publications (4)

  • Hirahashi T, Matsumoto M, Hazeki K, Saeki Y, Ui M, Seya T. Activation of the human innate immune system by Spirulina: augmentation of interferon production and NK cytotoxicity by oral administration of hot water extract of Spirulina platensis. Int Immunopharmacol. 2002 Mar;2(4):423-34. doi: 10.1016/s1567-5769(01)00166-7.

    PMID: 11962722BACKGROUND

  • Yakoot M, Salem A. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial. BMC Gastroenterol. 2012 Apr 12;12:32. doi: 10.1186/1471-230X-12-32.

    PMID: 22497849BACKGROUND

  • Pham TX, Park YK, Bae M, Lee JY. The Potential Role of an Endotoxin Tolerance-Like Mechanism for the Anti-Inflammatory Effect of Spirulina platensis Organic Extract in Macrophages. J Med Food. 2017 Mar;20(3):201-210. doi: 10.1089/jmf.2016.0119. Epub 2017 Jan 25.

    PMID: 28121488BACKGROUND

  • Munster VJ, Baas C, Lexmond P, Waldenstrom J, Wallensten A, Fransson T, Rimmelzwaan GF, Beyer WE, Schutten M, Olsen B, Osterhaus AD, Fouchier RA. Spatial, temporal, and species variation in prevalence of influenza A viruses in wild migratory birds. PLoS Pathog. 2007 May 11;3(5):e61. doi: 10.1371/journal.ppat.0030061.

    PMID: 17500589BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ming Shun Wu

    Taipei Municipal Wanfang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

October 29, 2019

Primary Completion

August 30, 2020

Study Completion

November 30, 2020

Last Updated

January 22, 2021

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)