NCT03924076

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 16, 2019

Last Update Submit

April 22, 2019

Conditions

Humoral Immune Response

Outcome Measures

Primary Outcomes (4)

  • Serum IgG

    Measuring IgG (ng/mL) in collected serum

    90 days

  • Serum IgA

    Measuring IgA (ng/mL) in collected serum

    90 days

  • Serum IgM

    Measuring IgM (ng/mL) in collected serum

    90 days

  • Faecal sIgA

    Measuring sIgA (ng/mL) in collected feses

    90 days

Secondary Outcomes (2)

  • Weight

    90 days

  • Height

    90 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

Received UHT milk (125 mL) for 90 days

Dietary Supplement: UHT Milk

Interventions

UHT Milk + Lactobacillus plantarum IS-10506DIETARY_SUPPLEMENT

125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group

Treatment Group
UHT MilkDIETARY_SUPPLEMENT

125 ml UHT milk given to placebo group

Placebo Group

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • allergic to milk
  • consuming other probiotic product
  • he/she do not want to stop consumption \& doing washout for 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Gadjah Mada

Sleman, D.I.Yogyakarta, 55281, Indonesia

Location

Study Officials

  • Siti Helmyati, DR.

    Gadjah Mada University

    PRINCIPAL INVESTIGATOR

  • Mohammad Juffrie, Prof.dr.

    Gadjah Mada University

    PRINCIPAL INVESTIGATOR

  • Lily A Lestari, DR.

    Gadjah Mada University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 23, 2019

Study Start

November 14, 2018

Primary Completion

January 4, 2019

Study Completion

April 4, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

ID(1)