Influenza, common infectious disease symptoms in flu-vaccinated elderly subjects Respiratory
Conditions
Interventions
50 elderly subjects, flu-vaccinated according to the national scheme, were enrolled and equally allocated (1:1) to either the placebo or probiotic group using a computer generated restricted randomize
Sponsors
Complife Italia Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 60 and 80 years on the day of inclusion 2. Able to comply with all the trial procedures 3. Inoculated with an influenza vaccine 4. Body Mass Index (BMI) between 18.5 and 24.99 5. Willing to not vary the normal daily routine (such as lifestyle and physical activity) 6. Willing to not alter their usual diet or fluid intake during the trial periods 7. Willing to follow the proposed alimentary supplement for all the study time 8. Willing to use during all the study period only the product to be tested 9. Willing to not use products likely to interfere with the product to be tested 10. Aware of the study procedures and signed an informed consent form
Exclusion criteria
Exclusion criteria: 1. Recently involved in any other similar study 2. Contraindications to influenza vaccinations 3. Undergoing treatment related to immune system modulation in the past 4 weeks 4. Therapy for immunosuppressants for >2 weeks, either currently or stopped <3 months before inclusion 5. Received an influenza vaccination <1 year before inclusion 6. Current antibiotic treatment 7. History of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency 8. Probiotic treatment within the 6 months before enrollment 9. Severe concurrent diseases 10. Drug abuse and/or alcohol abuse 11. Use of fiber products within the last 6 weeks 12. Dietary intake exceptionally high in plant-based, high fiber foods (such as fruits, vegetables, beans, whole grains, and fortified foods), including those following a strict vegetarian diet 13. Dietary intake of probiotics 14. Pre-existing hypersensitivity to components contained in the probiotic 15. Any condition that the principal investigator deems inappropriate for participation 16. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Common Infectious Disease (CID) symptoms either as the number of subjects who have CID symptoms or as number of days with the presence of CID symptoms as recorded in a study diary at baseline and 28 days 2. Calprotectin levels measured using an ELISA assay on stool samples collected at baseline and 28 days 3. Beta-defensin 2 levels measured using an ELISA assay on stool samples collected at baseline and 28 days 4. IgA levels measured using an ELISA assay on salivary samples collected at baseline and 28 days 5. Total Antioxidant Capacity measured using a FRAP assay on salivary samples collected at baseline and 28 days 6. Gut microbiota composition determined using V3-V4 16S NGS sequencing on DNA from stool samples collected at baseline and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CID symptoms measured as the number of subjects and number of days with CID symptoms between baseline and 56 days 2. Calprotectin levels measured using an ELISA assay on stool samples collected at 56 days 3. Beta-defensin 2 levels measured using an ELISA assay on stool samples collected at 56 days 4. IgA levels measured using an ELISA assay on salivary samples collected at 56 days 5. Total Antioxidant Capacity measured using a FRAP assay on salivary samples collected at 56 days 6. Gut microbiota composition determined using V3-V4 16S NGS sequencing on DNA from stool samples collected at 56 days | — |
Countries
Italy
Outcome results
None listed