NCT02909842

Effect of Drinking Fermented Milk on Immune Response

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Drinking fermented milk	Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-09-01
• Completion: 2017-08-01
• First posted: 2016-09-21
• Last updated: 2017-08-29