Influenza
Conditions
Keywords
influenza, vaccine, probiotic, immune response
Brief summary
This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.
Detailed description
This study is conducted in healthy volunteer using product approved by Thai FDA. This blinded randomized controlled trial compare immune response against influenza H1N1, H3N2 and Phu-B between study group and control group. The study group receives influenza vaccine and drinking fermented milk containing Lactobacillus paracasei (IMULUS), while the control group receives influenza vaccine and placebo acidified milk. The trial lasts for 8 weeks and include four time points of data collection (0, 2, 6, 8 weeks). Subjects, outcome assessor and investigators are blinded throughout the study.
Interventions
DIETARY_SUPPLEMENTDrinking fermented milk
Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
DIETARY_SUPPLEMENTplacebo
Acidified placebo milk with similar physical characteristics to the yoghurt drink
BIOLOGICALSeasonal Influenza Vaccine (H1N1, H3N2, PhuB)
Intramuscular injection of a single shot of influenza vaccine
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 45 years old * healthy and having normal vital signs * no history of uncontrolled systemic or autoimmune diseases * no signs or symptoms of respiratory infection * normal blood chemistry including complete blood count (CBC), liver and kidney function, lipid profile and fasting blood sugar * no history of influenza vaccine during the past 6 months * able to continuously take the intervention daily for 6 weeks * able to refrain from other probiotic products such as drinking fermented milk or yoghurt since the beginning till the end of data collection * accepted to receive influenza vaccine shot * able to refrain from receiving other vaccine during the trial * able to refrain from traveling to endemic area of influenza * able to communicate in Thai and sign their written inform consent
Exclusion criteria
* under pregnancy or expected to be pregnant * lactose or milk protein intolerances * daily intake of probiotic product for one month prior to recruitment * chronic alcoholism * GI disturbance e.g. stomachache, frequent diarrhea or constipation * history of GI surgery * ongoing treatment with antibiotic or other immune affecting drugs e.g. glucocorticoids, chemotherapy, antibodies, ciclosporin, hormone and opioids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response rate for H1N1, H3N2 and Phu-B virus | 4 weeks after vaccination | Number of subjects with increased HAI titer from baseline divided by total number of subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody response rate for influenza A (H1N1+H3N2) virus | 4 weeks after vaccination | Number of subjects with increased Immunoglobulin G or M (IgG or IgM) antibody levels from baseline divided by total number of subjects |
| Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus | 0, 2, 6 and 8 weeks after baseline | Changes in serum levels of IgM antibody against influenza A, detected by ELISA assay |
| Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus | 0, 2, 6 and 8 weeks after baseline | Changes in serum levels of IgG antibody against influenza A, detected by ELISA assay |
| Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus | 0, 2, 6 and 8 weeks after baseline | Changes in maximum dilution of serum, detected by Heme agglutination inhibition (HAI) assay , which can immunologically react against H1N1, H3N2 and Phu-B virus |
Outcome results
None listed