Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

Last updated: November 13, 2024
Sponsor: University of Mississippi Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Healthy Volunteers

Treatment

Immulina TM

Placebo

Immulina TM

Clinical Study ID

NCT05447078
2020-0020
1U19AT010838-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resilience to the effects of viral influenza infection in humans.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 18-59 (study group 1) or ages 65 and above (study group 2)

  • Any chronic illness must be determined (by PI team) to be stable as evidenced by nochanges in medical regimens within 30 days of enrollment.

  • Ability to comprehend the specific activities required to participate in the trialfor which the participant is to be enrolled.

Exclusion

Exclusion Criteria:

  • Any acute illness or significant injury within 30 days of enrollment.

  • Specific disease entities, which, in the opinion of the PI, could reasonably beassumed to have dysfunctional immune function as a component of their illness. Theseinclude HIV, AIDS, uncontrolled asthma, uncontrolled eczema, uncontrolled allergicrhinitis, uncontrolled urticaria, Rheumatoid arthritis, lupus, inflammatory boweldisease, multiple sclerosis, Type-1 diabetes mellitus, Guillain-Barr syndrome,Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis.

  • Active autoimmune diseases regardless of clinical stability. A history of autoimmunedisease that is not considered active (i.e. no medical therapy for at least 1 yearprior to enrollment) will not be excluded.

  • History of unstable chronic illness within 30 days of enrollment.

  • Unable/unwilling to commit to multiple research clinic visits which will bedescribed in detail.

Study Design

Total Participants: 472
Treatment Group(s): 3
Primary Treatment: Immulina TM
Phase: 3
Study Start date:
July 01, 2022
Estimated Completion Date:
June 30, 2026

Study Description

This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on increasing host resilience against the pathogenic effects of influenza virus infection in normal and immune compromised individuals by measuring a biomarker profile designed to reflect immune components associated with antiviral natural killer cell numbers and activity, cytotoxic T cell numbers, vaccine-related flu-specific antibody responses and cytokine profiles associated with host antiviral innate and adaptive immune responses.

Connect with a study center

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

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