Overview

This trial is active, not recruiting.

Condition influenza
Treatments drinking fermented milk, placebo, seasonal influenza vaccine (h1n1, h3n2, phub)
Sponsor Mahidol University
Start date February 2016
End date September 2016
Trial size 60 participants
Trial identifier NCT02909842, MU-CIRB 2015/145.2509

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS)
drinking fermented milk
Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
seasonal influenza vaccine (h1n1, h3n2, phub)
Intramuscular injection of a single shot of influenza vaccine
(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
placebo
Acidified placebo milk with similar physical characteristics to the yoghurt drink
seasonal influenza vaccine (h1n1, h3n2, phub)
Intramuscular injection of a single shot of influenza vaccine

Primary Outcomes

Measure
Immune response rate for H1N1, H3N2 and Phu-B virus
time frame: 4 weeks after vaccination

Secondary Outcomes

Measure
Antibody response rate for influenza A (H1N1+H3N2) virus
time frame: 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 from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus
time frame: 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

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model
Principal investigator Dunyaporn Trachootham, DDS, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mahidol University.