Effect of Drinking Fermented Milk on Immune Response

August 28, 2017 updated by: Dunyaporn Trachootham, Mahidol University

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

This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
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
Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
Intramuscular injection of a single shot of influenza vaccine
Placebo Comparator: control group
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
Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
Intramuscular injection of a single shot of influenza vaccine
Dietary supplement: placebo
Acidified placebo milk with similar physical characteristics to the yoghurt drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response rate for H1N1, H3N2 and Phu-B virus
Time Frame: 4 weeks after vaccination
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
Time Frame: 4 weeks after vaccination
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
Time Frame: 0, 2, 6 and 8 weeks after baseline
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
Time Frame: 0, 2, 6 and 8 weeks after baseline
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
Time Frame: 0, 2, 6 and 8 weeks after baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Dunyaporn Trachootham, DDS, PhD, Mahidol university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-CIRB 2015/145.2509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only summary of data will be reported. No individual data will be released.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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