Effect of Drinking Fermented Milk on Immune Response
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drinking fermented milk
placebo
Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, vaccine, probiotic, immune response
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
study group
control group
Arm Description
Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS)
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02909842
Brief Title
Effect of Drinking Fermented Milk on Immune Response
Official Title
Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (undefined)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, vaccine, probiotic, immune response
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS)
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Drinking fermented milk
Intervention Description
Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Acidified placebo milk with similar physical characteristics to the yoghurt drink
Intervention Type
Biological
Intervention Name(s)
Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
Intervention Description
Intramuscular injection of a single shot of influenza vaccine
Primary Outcome Measure Information:
Title
Immune response rate for H1N1, H3N2 and Phu-B virus
Description
Number of subjects with increased HAI titer from baseline divided by total number of subjects
Time Frame
4 weeks after vaccination
Secondary Outcome Measure Information:
Title
Antibody response rate for influenza A (H1N1+H3N2) virus
Description
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
Title
Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus
Description
Changes in serum levels of IgM antibody against influenza A, detected by ELISA assay
Time Frame
0, 2, 6 and 8 weeks after baseline
Title
Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus
Description
Changes in serum levels of IgG antibody against influenza A, detected by ELISA assay
Time Frame
0, 2, 6 and 8 weeks after baseline
Title
Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dunyaporn Trachootham, DDS, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only summary of data will be reported. No individual data will be released.
Learn more about this trial
Effect of Drinking Fermented Milk on Immune Response
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