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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03924076

Enrollment

Registered

2019-04-23

Start date

2018-11-14

Completion date

2019-04-04

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humoral Immune Response

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.

Interventions

DIETARY_SUPPLEMENTUHT Milk + Lactobacillus plantarum IS-10506

125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group

DIETARY_SUPPLEMENTUHT Milk

125 ml UHT milk given to placebo group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 9 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Serum IgG	90 days	Measuring IgG (ng/mL) in collected serum
Serum IgA	90 days	Measuring IgA (ng/mL) in collected serum
Serum IgM	90 days	Measuring IgM (ng/mL) in collected serum
Faecal sIgA	90 days	Measuring sIgA (ng/mL) in collected feses

Secondary

Measure	Time frame	Description
Weight	90 days	Measuring weight (kg) change
Height	90 days	Measuring height (cm) change

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026