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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
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, vaccine, probiotic, immune response

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 14, 2016
    Last Updated
    August 28, 2017
    Sponsor
    Mahidol University
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    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.

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    Effect of Drinking Fermented Milk on Immune Response

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