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

Study Overview
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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

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.

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

Conditions
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Humoral Immune Response

Intervention / Treatment
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* Dietary Supplement: UHT Milk + Lactobacillus plantarum IS-10506
* Dietary Supplement: UHT Milk


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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL) for 90 days | Dietary Supplement: UHT Milk + Lactobacillus plantarum IS-10506<br>* 125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group<br>|
| Placebo Comparator: Placebo Group<br>Received UHT milk (125 mL) for 90 days | Dietary Supplement: UHT Milk<br>* 125 ml UHT milk given to placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measuring weight (kg) change | 90 days | 
| Height | Measuring height (cm) change | 90 days |