Immulina Supplement for Enhancing Viral Resilience in Healthy Subjects

Overseen By Jamie L Brown, BSN, RN

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

Trial Summary

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.

What evidence supports the effectiveness of the drug Immulina TM for enhancing viral resilience?

Research on Pidotimod, a component of Immulina TM, shows it can boost the immune system, reducing infections and symptoms in conditions like respiratory tract infections and chronic bronchitis. It has been shown to improve immune responses and reduce the frequency and severity of infections, suggesting potential benefits for enhancing viral resilience. ^{1 2 3 4 5}

Is Immulina Supplement safe for human use?

The research articles provided do not contain specific safety data for Immulina or its related names. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How does the drug Immulina differ from other treatments for enhancing viral resilience?

Immulina, which includes Pidotimod, is unique because it acts as an immunomodulator, enhancing both innate and adaptive immune responses, and is shown to improve clinical conditions by reducing infection episodes and severity. Unlike other treatments, it can be taken orally and has a good safety profile with minimal side effects, making it a novel option for boosting immunity. ^{1 2 4 11 12}

What is the purpose of this trial?

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.

Research Team

Gailen D Marshall Jr., MD, PhD

Principal Investigator

University of Mississippi Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Immunomodulating activity of Pidotimod in children with Down syndrome. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Pidotimod: the state of art. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Immunoactivity of pidotimod against episodes of recurrent tonsillitis in childhood. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Non-specific immune stimulation in respiratory tract infections. Separating the wheat from the chaff. [2014]

5. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of pidotimod in the exacerbations in patients affected with chronic bronchitis. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Select Dietary Supplement Ingredients for Preserving and Protecting the Immune System in Healthy Individuals: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Immunonutrition: can you be what you eat? [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of standard and immune-enhancing oral formulas in asymptomatic HIV-infected persons: a multicenter randomized controlled clinical trial. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States 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. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Pidotimod and Immunological Activation in Individuals Infected with HIV. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Effect of food on the bioavailability of pidotimod in healthy volunteers. [2013]