Effect of Drinking Fermented Milk on Immune Response

Influenza Clinical Trial

Official title:

Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909842
• Other study ID #: MU-CIRB 2015/145.2509
• Status: Completed
• Phase: N/A
• First received: September 14, 2016
• Last updated: August 28, 2017
• Start date: January 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Dietary Supplement:
• Drinking fermented milk
Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
• placebo
Acidified placebo milk with similar physical characteristics to the yoghurt drink

Biological:
• Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
Intramuscular injection of a single shot of influenza vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response rate for H1N1, H3N2 and Phu-B virus	Number of subjects with increased HAI titer from baseline divided by total number of subjects	4 weeks after vaccination
Secondary	Antibody response rate for influenza A (H1N1+H3N2) virus	Number of subjects with increased Immunoglobulin G or M (IgG or IgM) antibody levels from baseline divided by total number of subjects	4 weeks after vaccination
Secondary	Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus	Changes in serum levels of IgM antibody against influenza A, detected by ELISA assay	0, 2, 6 and 8 weeks after baseline
Secondary	Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus	Changes in serum levels of IgG antibody against influenza A, detected by ELISA assay	0, 2, 6 and 8 weeks after baseline
Secondary	Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus	Changes in maximum dilution of serum, detected by Heme agglutination inhibition (HAI) assay , which can immunologically react against H1N1, H3N2 and Phu-B virus	0, 2, 6 and 8 weeks after baseline