Effect of Drinking Fermented Milk on Immune Response

NCT ID: NCT02909842

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-08-01

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

study group

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

Group Type: EXPERIMENTAL

Drinking fermented milk

Intervention Type: DIETARY_SUPPLEMENT

Drinking fermented milk containing Lactobacillus paracasei (IMULUS)

Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)

Intervention Type: BIOLOGICAL

Intramuscular injection of a single shot of influenza vaccine

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

Acidified placebo milk with similar physical characteristics to the yoghurt drink

Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)

Intervention Type: BIOLOGICAL

Intramuscular injection of a single shot of influenza vaccine

Interventions

Drinking fermented milk

Drinking fermented milk containing Lactobacillus paracasei (IMULUS)

Intervention Type: DIETARY_SUPPLEMENT

placebo

Acidified placebo milk with similar physical characteristics to the yoghurt drink

Intervention Type: DIETARY_SUPPLEMENT

Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)

Intramuscular injection of a single shot of influenza vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Dunyaporn Trachootham

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dunyaporn Trachootham, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Other Identifiers

MU-CIRB 2015/145.2509

Identifier Type: -

Identifier Source: org_study_id