immune modulation in healthy subjects immune support vaccination response
Conditions
Interventions
The active intervention group will receive Bifidobacterium lactis CECT 8145
BPL1® (BLP1®), as a food supplement. The placebo group will receive a
supplement in which BLP1® is replaced by maltodextri
Sponsors
ADM Biopolis
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age >=16 and =18.5 and
Exclusion criteria
Exclusion criteria: 1. Influenza vaccination within 6 months before the start of the intervention 2. Any vaccination in the month before randomization (visit 1) or any scheduled vaccination during the study period 3. Self-reported influenza infection within 6 months before the start of the intervention 4. Acute infection (including gastroenteritis) within 2 months before start of the intervention 5. Treatment with oral antibiotics within 2 months before the start of the intervention 6. Serious progressive disease or non-stabilized chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic kidney or liver disease) 7. Gastrointestinal disorders (e.g., inflammatory bowel disease) 8. Immunodeficiency or autoimmune disorder 9. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies) 10. Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to pre-study screening 11. Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use 12. No change in use of immune boosting supplements during the study 13. Mental status that is incompatible with the proper conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with either a pre-vaccination HAI titer = 1:40 or a pre-vaccination HAI titer >= 1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Geometric Mean Titre of influenza-specific antibodies • Seroprotection • Change in plasma cytokines (IL-10, IL-4, and TNF-alpha, IFN-gamma) • Vaccine-specific plasma IgG concentrations • Plasma total IgG concentrations • Symptoms of respiratory tract infections (RTI) • Gastrointestinal symptoms • Adverse Events | — |
Countries
Netherlands
Outcome results
None listed