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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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