Effect of Drinking Fermented Milk on Immune Response

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Dietary Supplement: Drinking fermented milk; Dietary Supplement: placebo; Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)

• Registration Number: NCT02909842
• Lead Sponsor: Mahidol University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-09-01
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Status Verified: 2017-08
• Study Completion: 2017-08-01
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Drinking fermented milk	Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS)
study group	Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)	Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS)
control group	placebo	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
control group	Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)	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

Primary Outcome Measures

Name	Time	Method
Immune response rate for H1N1, H3N2 and Phu-B virus	4 weeks after vaccination	Number of subjects with increased HAI titer from baseline divided by total number of subjects

Secondary Outcome Measures

Name	Time	Method
Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus	0, 2, 6 and 8 weeks after baseline	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	0, 2, 6 and 8 weeks after baseline	Changes in serum levels of IgG antibody against influenza A, detected by ELISA assay
Antibody response rate for influenza A (H1N1+H3N2) virus	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
Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus	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