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

Gadjah Mada University

Status: Completed

Conditions: Humoral Immune Response

Treatments: Dietary Supplement: UHT Milk; Dietary Supplement: UHT Milk + Lactobacillus plantarum IS-10506

Study type: Interventional

Funder types: Other

Identifiers

NCT03924076

KE/FK/293/EC/2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 7 to 9 years old

Volunteers: 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: UHT Milk + Lactobacillus plantarum IS-10506

Placebo Group

Placebo Comparator group

Description:

Received UHT milk (125 mL) for 90 days

Treatment:

Dietary Supplement: UHT Milk