Effect of Drinking Fermented Milk on Immune Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model

Conditions
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Influenza

Intervention / Treatment
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* Dietary Supplement: Drinking fermented milk
* Dietary Supplement: placebo
* Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS) | Dietary Supplement: Drinking fermented milk<br>* Drinking fermented milk containing Lactobacillus paracasei (IMULUS)<br>Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)<br>* Intramuscular injection of a single shot of influenza vaccine<br>|
| Placebo Comparator: control group<br>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 | Dietary Supplement: placebo<br>* Acidified placebo milk with similar physical characteristics to the yoghurt drink<br>Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)<br>* Intramuscular injection of a single shot of influenza vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, vaccine, probiotic, immune response