This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
Acidified placebo milk with similar physical characteristics to the yoghurt drink
Intramuscular injection of a single shot of influenza vaccine
Immune response rate for H1N1, H3N2 and Phu-B virus
Number of subjects with increased HAI titer from baseline divided by total number of subjects
Time frame: 4 weeks after vaccination
Antibody response rate for influenza A (H1N1+H3N2) virus
Number of subjects with increased Immunoglobulin G or M (IgG or IgM) antibody levels from baseline divided by total number of subjects
Time frame: 4 weeks after vaccination
Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus
Changes in serum levels of IgM antibody against influenza A, detected by ELISA assay
Time frame: 0, 2, 6 and 8 weeks after baseline
Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus
Changes in serum levels of IgG antibody against influenza A, detected by ELISA assay
Time frame: 0, 2, 6 and 8 weeks after baseline
Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus
Changes in maximum dilution of serum, detected by Heme agglutination inhibition (HAI) assay , which can immunologically react against H1N1, H3N2 and Phu-B virus
Time frame: 0, 2, 6 and 8 weeks after baseline
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