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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL) for 90 days |
|
| Placebo Group | Placebo Comparator | Received UHT milk (125 mL) for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UHT Milk + Lactobacillus plantarum IS-10506 | Dietary Supplement | 125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Measuring weight (kg) change | 90 days |
| Height | Measuring height (cm) change | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siti Helmyati, DR. | Gadjah Mada University | Principal Investigator |
| Mohammad Juffrie, Prof.dr. | Gadjah Mada University | Principal Investigator |
| Lily A Lestari, DR. | Gadjah Mada University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Gadjah Mada | Sleman | D.I.Yogyakarta | 55281 | Indonesia |
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| UHT Milk | Dietary Supplement | 125 ml UHT milk given to placebo group |
|