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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2019-04-04

Brief Summary

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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

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Detailed Description

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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

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Humoral Immune Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment Group

Received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL) for 90 days

Group Type EXPERIMENTAL

UHT Milk + Lactobacillus plantarum IS-10506

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Group

Received UHT milk (125 mL) for 90 days

Group Type PLACEBO_COMPARATOR

UHT Milk

Intervention Type DIETARY_SUPPLEMENT

125 ml UHT milk given to placebo group

Interventions

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UHT Milk + Lactobacillus plantarum IS-10506

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

Intervention Type DIETARY_SUPPLEMENT

UHT Milk

125 ml UHT milk given to placebo group

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.