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

April 22, 2019 updated by: DR.Siti Helmyati, DCN, M.Kes, Gadjah Mada University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • D.I.Yogyakarta
      • Sleman, D.I.Yogyakarta, Indonesia, 55281
        • Universitas Gadjah Mada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
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
125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group
Placebo Comparator: Placebo Group
Received UHT milk (125 mL) for 90 days
Dietary supplement: UHT Milk
125 ml UHT milk given to placebo group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2018

Primary Completion (Actual)

January 4, 2019

Study Completion (Actual)

April 4, 2019

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • KE/FK/293/EC/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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