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

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.

• UHT Milk + Lactobacillus plantarum IS-10506 (Dietary supplement): 125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group
• UHT Milk (Dietary supplement): 125 ml UHT milk given to placebo group

Primary outcomes

• 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 outcomes

• Weight [90 days]: Measuring weight (kg) change
• Height [90 days]: Measuring height (cm) change

Sex: All, ages: 7 Years to 9 Years, accepts healthy volunteers

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.

• Siti Helmyati, DR., Principal investigator, Gadjah Mada University
• Mohammad Juffrie, Prof.dr., Principal investigator, Gadjah Mada University
• Lily A Lestari, DR., Principal investigator, Gadjah Mada University