Probiotics and Immunity
Phase 3
- Registration Number
- CTRI/2018/11/016333
- Lead Sponsor
- nique Biotech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children aged 3- 14 years who have not vaccinated with influenza virus previously.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Humoral response measure by following parameters: <br/ ><br>Total antibody titers (IgG, IgA and IgM) <br/ ><br>Timepoint: Beginning of the study ( Day 1) <br/ ><br>Before vaccination ( day 14) <br/ ><br>One month after vaccination (Day 42)
- Secondary Outcome Measures
Name Time Method cytokines TNFα, IFNγ, IL12 and IL10). <br/ ><br>Influenza specific immunoglobulins (IgG, IgM and IgA) level estimation <br/ ><br>Timepoint: Beginning of the study ( Day 1) <br/ ><br>Before vaccination ( day 14) <br/ ><br>One month after vaccination (Day 42)