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

Not Applicable

Completed

• Conditions: Humoral Immune Response
• Interventions: Dietary Supplement: UHT Milk + Lactobacillus plantarum IS-10506; Dietary Supplement: UHT Milk

• Registration Number: NCT03924076
• Lead Sponsor: Gadjah Mada University

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 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.

Study Timeline

• Study Start: 2018-11-14
• Primary Completion: 2019-01-04
• Status Verified: 2019-04
• Study Completion: 2019-04-04
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Study First Posted: 2019-04-23
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• children at age of 7-9 years
• have normal body mass index (BMI) i.e. -2 ≤ z-score < +1, slightly overweight z-score < +1.5, and slightly underweight z-score > -3.

Exclusion Criteria

• allergic to milk
• consuming other probiotic product
• he/she do not want to stop consumption & doing washout for 2 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	UHT Milk + Lactobacillus plantarum IS-10506	Received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL) for 90 days
Placebo Group	UHT Milk	Received UHT milk (125 mL) for 90 days

Primary Outcome Measures

Name	Time	Method
Serum IgG	90 days	Measuring IgG (ng/mL) in collected serum
Faecal sIgA	90 days	Measuring sIgA (ng/mL) in collected feses
Serum IgA	90 days	Measuring IgA (ng/mL) in collected serum
Serum IgM	90 days	Measuring IgM (ng/mL) in collected serum

Secondary Outcome Measures

Name	Time	Method
Weight	90 days	Measuring weight (kg) change
Height	90 days	Measuring height (cm) change

Trial Locations

Locations (1)

Universitas Gadjah Mada; 🇮🇩 Sleman, D.I.Yogyakarta, Indonesia