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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS) |
|
| control group | Placebo Comparator | Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of placebo, unlabelled acidified milk with similar physical and sensory appearance to the experimental one |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinking fermented milk | Dietary Supplement | Drinking fermented milk containing Lactobacillus paracasei (IMULUS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after vaccination |
| Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dunyaporn Trachootham, DDS, PhD | Mahidol University | Principal Investigator |
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Only summary of data will be reported. No individual data will be released.
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| placebo | Dietary Supplement | Acidified placebo milk with similar physical characteristics to the yoghurt drink |
|
| Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) | Biological | Intramuscular injection of a single shot of influenza vaccine |
|
Changes in serum levels of IgM antibody against influenza A, detected by ELISA assay |
| 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 | 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 | 0, 2, 6 and 8 weeks after baseline |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |