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

Humoral Immune Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924076
• Other study ID #: KE/FK/293/EC/2018
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: April 4, 2019

Study information

• Verified date: April 2019
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 4, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Humoral Immune Response

Intervention

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

Locations

Country	Name	City	State
Indonesia	Universitas Gadjah Mada	Sleman	D.I.Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum IgG	Measuring IgG (ng/mL) in collected serum	90 days
Primary	Serum IgA	Measuring IgA (ng/mL) in collected serum	90 days
Primary	Serum IgM	Measuring IgM (ng/mL) in collected serum	90 days
Primary	Faecal sIgA	Measuring sIgA (ng/mL) in collected feses	90 days
Secondary	Weight	Measuring weight (kg) change	90 days
Secondary	Height	Measuring height (cm) change	90 days