Immulina Supplement for Enhancing Viral Resilience in Healthy Subjects

Overseen By Gailen D. Marshall, Jr., MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Mississippi Medical Center

Disqualifiers: HIV, AIDS, Uncontrolled asthma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

472 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an oral supplement called Immulina TM (also known as Pidotimod or Immulina Liquid) might help people resist the flu. Participants will receive either different doses of Immulina or a placebo, a harmless pill with no active ingredients. The goal is to determine if Immulina can enhance flu resistance. The trial seeks participants who are healthy, do not have severe allergies or autoimmune diseases, and have stable chronic illnesses without recent medication changes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking flu prevention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but your chronic illness must be stable with no changes in your medical regimen for at least 30 days before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Immulina is generally safe and helps strengthen the immune system, protecting the body from germs and viruses. It has been used to prevent respiratory illnesses, like the flu, by increasing the body's resistance to infections.

In studies with Immulina nanosuspensions, researchers observed activation of immune cells in animal tests, suggesting it might help the immune system fight infections. These findings indicate that Immulina is well-tolerated by the body. This trial is in a late phase, which usually means more information about the treatment's safety is available from earlier studies. While more data from human trials will provide a clearer picture, current research supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Immulina because it offers a unique approach to boosting viral resilience by using a natural dietary supplement. Unlike standard antiviral treatments that often focus on directly targeting viruses, Immulina works by enhancing the body's immune response. The active ingredient is derived from Spirulina, a type of blue-green algae known for its immune-boosting properties. This makes Immulina a potentially safer and more holistic option for enhancing viral resilience in healthy individuals. Additionally, its administration as a simple oral supplement could offer an easy-to-use alternative to more complex antiviral therapies.

What evidence suggests that Immulina TM could be an effective treatment for viral resilience?

Research has shown that Immulina® might help the body combat viral infections like the flu. Studies have found that taking Immulina® before or soon after virus exposure can boost the immune system, aiding the body in fighting the virus. One study demonstrated that Immulina® can help protect against the flu when used preventatively. This trial will test different dosages of Immulina® to evaluate its effectiveness in strengthening the immune system's response to viral infections. These findings suggest that Immulina® could be a helpful supplement for enhancing viral resilience. ^{6 7 8 9 10}

Who Is on the Research Team?

Gailen D Marshall Jr., MD, PhD

Principal Investigator

University of Mississippi Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy adults in two age groups: 18-59 and 65 or older. Participants must have stable chronic illnesses, with no changes to their medical treatments within the last month. They should understand what's required for the study and be able to attend multiple clinic visits.

Inclusion Criteria

Ability to comprehend the specific activities required to participate in the trial for which the participant is to be enrolled.

My chronic illness has been stable for at least 30 days.

Exclusion Criteria

I am unable to commit to multiple clinic visits for research.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Immulina TM or placebo for 16 weeks to assess immune resilience against influenza

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immulina TM
• Placebo

Trial Overview The trial tests Immulina TM, an oral supplement, against a placebo to see if it can boost resilience against viral influenza infection. It's a randomized, double-blind study meaning participants are randomly assigned to either the supplement or placebo group without knowing which one they receive.

How Is the Trial Designed?

Group I: Immulina TM 800 mg/day Experimental Treatment 1 Intervention

Immulina Dietary supplementation (200 mg per capsule); 2-200 mg capsules given by mouth in the morning and 2-200 mg capsules given by mouth in the evening for 16 weeks duration.

Group II: Immulina TM 400 mg/day Experimental Treatment 1 Intervention

Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 1-200 mg capsule and 1 placebo capsule given by mouth in the evening for 16 weeks duration.

Group III: Immulina TM 200 mg/day Experimental Treatment 1 Intervention

Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 2 placebo capsules given by mouth in the evening for 16 weeks duration.

Group IV: Placebo Placebo Group 1 Intervention

inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 16 weeks duration.

Immulina TM is already approved in India for the following indications:

Approved in India as Pidotimod for:

• Recurrent upper and lower respiratory tract infections
• Acute respiratory tract infections
• Asthma
• Chronic obstructive pulmonary disorders
• Chronic bronchitis
• Immunological disorders
• Urinary tract infections

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials

185

Recruited

200,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Pidotimod, an immunostimulating dipeptide-like molecule, showed reduced bioavailability when taken with food, leading to a 50% decrease in maximum concentration and area under the curve (AUC) values compared to fasting conditions.

Despite the impact of food on absorption, the pharmacokinetics of pidotimod, such as half-life and mean residence time, remained unchanged, indicating that the drug's effectiveness is not affected after it is absorbed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of food on the bioavailability of pidotimod in healthy volunteers. D'Angelo, L., De Ponti, F., Crema, F., et al.[2013]

Pidotimod is an effective immunostimulant that improves clinical conditions and enhances immune cell functions in patients, particularly children and the elderly, suffering from recurrent respiratory tract infections.

The drug has a good safety profile with minimal side effects and is associated with reduced infection rates, less severe symptoms, and decreased reliance on antibiotics, making it a safer option for patients undergoing vaccination compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pidotimod: the state of art. Ferrario, BE., Garuti, S., Braido, F., et al.[2020]

In a study involving 18 children with Down Syndrome, Pidotimod, an immunostimulant, was found to enhance immune responses when given alongside the influenza vaccine, suggesting it may help reduce acute respiratory infections in this population.

The treatment with Pidotimod led to increased activation of genes related to innate immunity and a shift in the balance of Flu-specific antibodies, indicating a potential mechanism for improved vaccine efficacy and immune protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunomodulating activity of Pidotimod in children with Down syndrome. Zuccotti, GV., Mameli, C., Trabattoni, D., et al.[2013]

Many parents are influenced by advertisements to seek 'immune-stimulating enhancements' for their children with recurrent respiratory infections, despite a lack of scientific evidence supporting these products.

The review emphasizes the importance of ruling out any underlying immunodeficiency in children with recurrent respiratory infections before considering the use of marketed immune-boosting supplements, which often lack peer-reviewed studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-specific immune stimulation in respiratory tract infections. Separating the wheat from the chaff. Feleszko, W., Ruszczyński, M., Zalewski, BM.[2014]

Immunonutrition, which includes nutrients like glutamine, omega-3 fatty acids, and arginine, has been studied for its potential to influence immune responses, but individual supplements generally showed no significant clinical efficacy in randomized controlled trials.

Commercial immunonutrition formulas have demonstrated better outcomes compared to standard nutrition support in some trials, but design flaws in these studies make it unclear whether the benefits are due to the immunonutrients themselves or the overall nutrition regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunonutrition: can you be what you eat? Koretz, RL.[2019]

Immunonutrition, which includes dietary components like glutamine and omega-3 fatty acids, has been shown in randomized controlled trials to improve outcomes compared to standard nutritional support in patients.

There is currently no data from randomized trials comparing immunonutrition to no nutritional support, and the effects of these immunonutrients may vary depending on the specific disease state, suggesting they could act more like pharmacologic agents than just dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunonutrition: fact, fantasy, and future. Koretz, RL.[2022]

In a study involving 235 children with recurrent tonsillitis, pidotimod significantly reduced the incidence of tonsillitis recurrences and related symptoms over a 165-day trial period, demonstrating its efficacy as a therapeutic option.

Pidotimod was found to have a very low incidence of adverse effects, comparable to the placebo group, indicating that it is a safe treatment for managing recurrent tonsillitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunoactivity of pidotimod against episodes of recurrent tonsillitis in childhood. Motta, G., De Campora, E., De Vita, C., et al.[2013]

A systematic review of 39 randomized controlled studies evaluated the efficacy of dietary supplements like echinacea, elderberry, and vitamins A, C, D, E, and zinc in supporting immune health during stressors such as intense exercise and winter weather.

While some studies suggest potential benefits of these supplements for immune resilience, significant gaps in the evidence prevent definitive conclusions about their overall effectiveness and safety, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Select Dietary Supplement Ingredients for Preserving and Protecting the Immune System in Healthy Individuals: A Systematic Review. Crawford, C., Brown, LL., Costello, RB., et al.[2022]

In a study involving 90 asymptomatic HIV-infected individuals over 12 months, both standard (Ensure Plus) and immune-enhancing oral formulas showed no significant differences in nutrition and immune measures, including body weight and CD4+ T lymphocyte counts.

Participants tolerated both formulas well, indicating high acceptability, but the study concluded that neither formula provided additional benefits in nutrition or immune function for individuals with asymptomatic HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of standard and immune-enhancing oral formulas in asymptomatic HIV-infected persons: a multicenter randomized controlled clinical trial. Keithley, JK., Swanson, B., Zeller, JM., et al.[2017]

In a study involving 11 healthy subjects, a blend of botanicals (APR extract) significantly increased levels of immune-related chemokines and activated immune cells within hours of consumption, indicating enhanced immune surveillance.

The APR extract not only boosted immune cell alertness through activation markers but also improved antioxidant enzyme activity, suggesting it may provide protective benefits against oxidative stress while enhancing natural immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid increase in immune surveillance and expression of NKT and γδT cell activation markers after consuming a nutraceutical supplement containing Aloe vera gel, extracts of Poria cocos and rosemary. A randomized placebo-controlled cross-over trial. Yu, L., McGarry, S., Cruickshank, D., et al.[2023]

In a multicenter study involving 181 patients with chronic bronchitis, pidotimod significantly reduced the frequency of infectious relapses compared to placebo, with only 9% of pidotimod-treated patients experiencing relapses in the first month versus 39.5% in the placebo group.

The efficacy of pidotimod continued into the second month, with only 1.2% of patients on pidotimod reporting infectious episodes compared to 46.1% in the placebo group, demonstrating its potential as an effective treatment for preventing infections in chronic bronchitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of pidotimod in the exacerbations in patients affected with chronic bronchitis. Bisetti, A., Ciappi, G., Bariffi, F., et al.[2013]

In a pilot study involving 40 HIV-positive individuals, Pidotimod supplementation led to a significant rebalancing of pro-inflammatory and anti-inflammatory cytokines, suggesting it may help manage residual inflammation in this population.

Participants receiving Pidotimod also experienced a notable reduction in cystatin C levels and an increase in salivary IgA, indicating potential improvements in immune function and inflammation control after just 4 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pidotimod and Immunological Activation in Individuals Infected with HIV. Ucciferri, C., Falasca, K., Reale, M., et al.[2021]

Citations

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From Legacy to Innovation: Pidotimod's Expanding ... The study suggested that Pidotimod may help accelerate healing by boosting the innate immune response to the viral infection. Further ...

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Immulina® mitigates the development of illness when ... This study, together with our previous paper, indicate that Immulina® was most effective at enhancing immune antiviral resilience if administered before or soon ...

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Immulina® mitigates the development of illness when ... This study, together with our previous paper, indicate that Immulina® was most effective at enhancing immune antiviral resilience if administered before or soon

4. withpower.com withpower.com/trial/phase-healthy-subjects-hs-6-2022-e20ba

Immulina Supplement for Enhancing Viral Resilience in ... This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resilience to the ...

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Prophylactic and therapeutic mouse models for evaluating ... This study demonstrates that Immulina® exerts a protective effect against influenza illness when administered using a prophylactic regime.

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Immulina Liquid: View Uses, Side Effects, Price and ... - 1mg Immulina Liquid is a prescription medicine used to prevent diseases of the respiratory tract. It helps to improve and increase immunity.

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Immulina as an Immunostimulatory Supplement Immulina nanosuspension was found to stimulate the production of proinflammatory cytokines in murine bone marrow-derived dendritic cells and macrophages.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11661399/

Pidotimod in pediatrics: new evidence and future ... Evidence shows that pidotimod effectively and safely prevents respiratory infections, mainly in children with recurrent and frequent infectious episodes.

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Pidotimod: Uses, Side Effects and Medicines Pidotimod is used to strengthen the immune system and reduce the frequency of respiratory tract infections. The detailed uses of Pidotimod include: • Treatment ...

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Immulina Liquid - Uses, Dosage, Side Effects, Price, ... Immulina Liquid is used for the prevention and treatment of respiratory and urinary tract infections in patients with a compromised immune system.