Clinical trial NCT02909842: Effect of Drinking Fermented Milk on Immune Response
Official title: Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: influenza
vaccine
probiotic
immune response
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Immune response rate for H1N1, H3N2 and Phu-B virus
timeFrame: 4 weeks after vaccination
Secondary outcomes:
measure: Antibody response rate for influenza A (H1N1+H3N2) virus
timeFrame: 4 weeks after vaccination
measure: Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus
timeFrame: 0, 2, 6 and 8 weeks after baseline
measure: Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus
timeFrame: 0, 2, 6 and 8 weeks after baseline
measure: Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus
timeFrame: 0, 2, 6 and 8 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Dunyaporn Trachootham, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: