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Completed

NCT Number: NCT03924076

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

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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Key information

Conditions

Humoral Immune Response

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Gadjah Mada

Sleman, D.I.Yogyakarta, 55281, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Serum IgG

    Time frame: 90 days

    Measuring IgG (ng/mL) in collected serum

  2. Serum IgA

    Time frame: 90 days

    Measuring IgA (ng/mL) in collected serum

  3. Serum IgM

    Time frame: 90 days

    Measuring IgM (ng/mL) in collected serum

  4. Faecal sIgA

    Time frame: 90 days

    Measuring sIgA (ng/mL) in collected feses

Secondary outcomes

  1. Weight

    Time frame: 90 days

    Measuring weight (kg) change

  2. Height

    Time frame: 90 days

    Measuring height (cm) change

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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