Ignite Creation Date:
2024-05-06 @ 1:03 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03924076
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2019-04-16
Brief Title:
Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Elementary School Children
Sponsor:
Gadjah Mada University
Organization:
Gadjah Mada University
Study Overview
Official Title:
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
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 CFUday 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 ie faecal sIgA blood IgG IgM and IgA The subjects recruited from elementary school in Yogyakarta District
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None