Using Spirulina to Boost Resistance Against Viral Infections
Impact of Oral Immulina TM on Natural Killer Cell Activities and Other Biomarkers Associated With Increasing Host Immune Resilience to Upper Respiratory Viruses in Normal Human Volunteers
This study is testing if a supplement called Immulina TM can help both healthy and immune-compromised people boost their immune response against the flu virus.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 472 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Mississippi Medical Center Academic / other |
| Locations | 1 site (Jackson, Mississippi) |
| Trial ID | NCT05447078 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled study evaluates the effects of the oral supplement Immulina TM on enhancing the body's resilience to influenza virus infections. The study focuses on measuring various immune response biomarkers, including natural killer cell activity, cytotoxic T cell counts, and flu-specific antibody responses in both healthy and immune-compromised individuals. Participants will be monitored for changes in their immune profiles to determine the supplement's efficacy in improving antiviral responses.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-59 or seniors aged 65 and above with stable chronic illnesses.
Not a fit: Patients with acute illnesses, significant injuries, or active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural dietary supplement option to enhance immune resilience against viral infections like influenza.
How similar studies have performed: Other studies have shown promise in using dietary supplements to enhance immune function, but this specific approach with Immulina TM is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 no changes in medical regimens within 30 days of enrollment. * Ability to comprehend the specific activities required to participate in the trial for which the participant is to be enrolled. 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 be assumed to have dysfunctional immune function as a component of their illness. These include HIV, AIDS, uncontrolled asthma, uncontrolled eczema, uncontrolled allergic rhinitis, uncontrolled urticaria, Rheumatoid arthritis, lupus, inflammatory bowel disease, 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 autoimmune disease that is not considered active (i.e. no medical therapy for at least 1 year prior 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 be described in detail.
Where this trial is running
Jackson, Mississippi
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
Study contacts
- Principal investigator: Gailen D Marshall Jr., MD, PhD — University of Mississippi Medical Center
- Study coordinator: Thomas M Hudson, BS
- Email: tmhudson@umc.edu
- Phone: 601-496-7808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.