Effect of Drinking Fermented Milk on Immune Response

Mahidol University

Status: Completed

Conditions: Influenza

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02909842

MU-CIRB 2015/145.2509

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS)

Treatment:

Dietary Supplement: Drinking fermented milk

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

control group

Placebo Comparator group

Description:

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

Treatment:

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

Dietary Supplement: placebo