None listed
Conditions
Interventions
Intervention1: Bacillus coagulans Unique IS2 suspension: Each 5 ml oral suspension mini bottle contains
Bacillus coagulans Unique IS2-2 billion spores and
Purified water-q.s.
To be administered orall
Sponsors
Unique Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3- 14 years who have not vaccinated with influenza virus previously.
Exclusion criteria
Exclusion criteria: Presence of acute/terminal disease Daily consumption of probiotic products 1 month before the start of the study Frequent gastrointestinal disorders Gastrointestinal surgery Antibiotic treatment or treatment with any other drug known to affect the immune response during the trial Any vaccination taken 15 days prior to study Had already received vaccination Participating in any other clinical study suffered from hepatitis recently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Humoral response measure by following parameters: Total antibody titers (IgG, IgA and IgM) Timepoint: Beginning of the study ( Day 1) Before vaccination ( day 14) One month after vaccination (Day 42) | — |
Secondary
| Measure | Time frame |
|---|---|
| cytokines TNFα, IFNγ, IL12 and IL10). Influenza specific immunoglobulins (IgG, IgM and IgA) level estimation Timepoint: Beginning of the study ( Day 1) Before vaccination ( day 14) One month after vaccination (Day 42) | — |
Countries
India
Contacts
Public ContactDr N Jayanthi
Kamineni Academy of Medical Science and Research Centre
Outcome results
None listed