NCT03924076

Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Elementary School Children

Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Indonesian Elementary School Children: a Double Blind, Randomized, Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Gadjah Mada University · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Accepted

Summary

This study is aimed to determine effect of paraprobiotic Lactobacillus plantarum IS-10506 on humoral immune response by measuring faecal sIgA and blood IgG, IgM, and IgA

Detailed description

The type of the study is double blind randomize placebo-controlled trial with minimum 72 subjects which divided into 2 groups i.e. 1) placebo group which will receive UHT milk (125 mL) and 2) treatment group which will received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL). The subjects have to consume one pack of milk every day for 90 consecutive days. Before and after intervention (day 30 and day 90), several data will be collected i.e. faecal sIgA, blood IgG, IgM, and IgA. The subjects recruited from elementary school in Yogyakarta District.

Conditions

• Humoral Immune Response

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	UHT Milk + Lactobacillus plantarum IS-10506	125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group
DIETARY_SUPPLEMENT	UHT Milk	125 ml UHT milk given to placebo group

Timeline

• Start date: 2018-11-14
• Primary completion: 2019-01-04
• Completion: 2019-04-04
• First posted: 2019-04-23
• Last updated: 2019-04-23

Locations

1 site across 1 country: Indonesia