Covid19 Clinical Trial
Official title:
Efficacy and Tolerability of a Nutritional Supplementation With ABBC-1, a Symbiotic Combination of Beta-glucans and Selenium and Zinc Enriched Probiotics, in Volunteers Receiving the Influenza or the Covid-19 Vaccines
Verified date | July 2022 |
Source | AB Biotek |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions. Innate immunity can adapt and respond more efficiently to secondary exposures, thanks to epigenetic and metabolic reprogramming, namely "trained immunity". ABBC1 is a combination of beta-1,3/1,6-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for training immunity. ABBC1 includes repurposed synergistic yeast-based ingredients: a unique ß-1,3/1,6-glucan complex and a consortium of probiotic Saccharomyces cerevisiae, rich in Selenium and Zinc. ABBC1 induces trained immunity due to its specific chemical and tridimensional structure: its ß-glucan complex interacts with specific receptors in immune cells, provoking a release of cytokines and priming phagocytosis. Simultaneous activation of these pathways activates innate immunity and counteracts cytokine storm. ABBC1 provides highly bioavailable selenium and zinc, micronutrients with a critical role in an optimal immune responsiveness to allergy, infection, and vaccines. ABBC1 possesses proven microbiome modulating properties, which revert in immune training. Due to its high tolerance, safety and immediate availability, ABBC1 is an ideal candidate for complementary management of geriatric patients with seasonal influenza viruses or COVID-19, or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines. The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients, including the elderly who are frequently polymedicated, and allows adding an additional therapeutic tool in the fight against the pandemic. This study assesses the benefits of a nutritional supplementation with ABBC1 in volunteers receiving the influenza vaccine during autumn 2020 and the Covid-10 vaccine during winter 2021.
Status | Completed |
Enrollment | 72 |
Est. completion date | September 24, 2021 |
Est. primary completion date | June 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: COMMON CRITERIA: - Subjects with the ability to take the study product orally - Ability to understand the study, the information about the symptoms and to comply with the treatment shots. - Subject or legal guardian / representative willing to give informed consent in writing. INFLUENZA VACCINE GROUPS: - Subjects who require hospitalization or external follow-up (outpatients or PADES) - Subjects over 60 years old who will receive the influenza vaccine COVID-19 VACCINE GROUPS - Subjects from long-stay centres attached to the Hospital Mare de Déu de la Mercè, and meet the following inclusion criteria: - Groups: - Subjects over 18 years of age who receive the Covid-19 vaccine, in a stable clinical situation, at the discretion of the researcher, or - Healthcare workers of the study centers, over 18 years of age who receive the Covid-19 vaccine - Availability to attend clinical visits. Exclusion Criteria: COMMON CRITERIA: - Need for assisted ventilation that makes oral consumption of the product under study impossible - History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients. - History or evidence of any medical conditions or medication use that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations - Subjects in situation of last days COVID-19 VACCINE GROUPS: - Subjects in whom the Covid-19 vaccine is contraindicated. - A history of frailty or comorbidity that indicates a situation of clinical instability. - History or evidence of any medical conditions or drug use that, in the opinion of the principal investigator, could affect the safety of subjects or interfere with study evaluations. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Mare de Déu de la Mercè - Germanes Hospitalàries | Barcelona |
Lead Sponsor | Collaborator |
---|---|
AB Biotek |
Spain,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood analysis (Influenza vaccine groups) | Alterations in the blood count and in inflammatory or immune function markers | 30 days | |
Other | Blood analysis (Covid-19 vaccine groups) | Alterations in the blood count and in inflammatory or immune function markers | 35 days | |
Primary | Change in the acute immune response to the influenza vaccine after supplementation (influenza vaccine groups) | Generation of T-cells (TCD8, TCD3 and TCCD4) | 30 days (Days 1, 7 and 30) | |
Primary | Change in the delayed immune response to the influenza vaccine after supplementation (influenza vaccine groups) | Generation of influenza-specific antibodies (IgM, IgG influenza A and B) | 30 days (Days 1, 7 and 30) | |
Primary | Change in the acute immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups) | Generation of T-cells (TCD8, TCD3 and TCCD4) | 35 days (Days 1, 7, 21 and 35) | |
Primary | Change in the delayed immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups) | Generation of influenza-specific antibodies (IgM, IgG influenza A and B) | 35 days (Days 1, 7, 21 and 35) | |
Primary | Change in blood levels of selenium and zinc | Variation of selenium and zinc levels measured in plasma | 30 days (Days 1, 7 and 30) for influenza vaccine groups. 35 days (Days 1, 7, 21 and 35) for Covi-19 groups. | |
Secondary | Incidence of influenza (only for influenza vaccine groups) | Number of volunteers presenting influenza as measured by clinical diagnostic | 30 days | |
Secondary | Incidence of Covid-19 | Number of volunteers presenting Covid-19 as measured by clinical diagnostic and/or PCR or antigen test | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups | |
Secondary | Mean Change in the Ordinal Scale WHO R&D Blueprint novel Coronavirus | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement. | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups | |
Secondary | Number of subjects with fever during the study | Variation on body temperature (ºC) | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups | |
Secondary | Number of subjects with cough during the study | Clinical assessment | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups | |
Secondary | Number of subjects with myalgia during the study | Clinical assessment | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups | |
Secondary | Number of subjects with dyspnea during the study | Clinical assessment | 30 days for influenza groups, 35 days for Covid-19 groups | |
Secondary | Number of subjects with anosmia / ageusia during the study | Clinical assessment | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups | |
Secondary | Hospital readmission rate during the study and the additional follow-up period | percentage of patients readmitted to the hospital during the study and the addition follow-up period | 60 days | |
Secondary | Changes in blood glucose | measured in blood samples | 30 days for influenza groups, 35 days for Covid-19 groups | |
Secondary | Incidence of adverse effects of the study product | reporting of adverse events (if any) | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups | |
Secondary | Dietary history | Record of the dietary history during the study | 30 days for influenza vaccine groups, 35 days for Covid-19 vaccine groups |
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