Effect of Drinking Fermented Milk on Immune Response

NCT02909842 | Completed

• 1 other identifier: MU-CIRB 2015/145.2509
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza

Keywords

influenza; vaccine; probiotic; immune response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Antibody response rate for influenza A (H1N1+H3N2) virus

  4 weeks after vaccination

• Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus

  0, 2, 6 and 8 weeks after baseline

• Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus

  0, 2, 6 and 8 weeks after baseline

• Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus

  0, 2, 6 and 8 weeks after baseline

Study Arms (2)

study group

EXPERIMENTAL

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; Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)

control group

PLACEBO COMPARATOR

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; Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)

Interventions

Drinking fermented milk DIETARY_SUPPLEMENT

Drinking fermented milk containing Lactobacillus paracasei (IMULUS)

study group

placebo DIETARY_SUPPLEMENT

Acidified placebo milk with similar physical characteristics to the yoghurt drink

control group

Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) BIOLOGICAL

Intramuscular injection of a single shot of influenza vaccine

control group; study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Dunyaporn Trachootham, DDS, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 21, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share