NCT02434042

Brief Summary

This project aims to study the benefits of probiotics namely Bifidobacterium longum BB536 in prevention of acute diarrhea and/or respiratory-related illnesses, which are found common among children in Malaysia aged from 2 to 6 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

April 29, 2015

Last Update Submit

November 2, 2017

Conditions

Healthy Volunteers

Keywords

probioticchildrengastrointestinalupper respiratory

Outcome Measures

Primary Outcomes (3)

  • Absentia between BB536 vs. Placebo children in daycare centers due to diarrhea and/or respiratory-related illnesses

    10 monhts

  • Severity of diarrhea between BB536 vs. Placebo children

    10 months

  • Severity of respiratory-related illnesses between BB536 vs. Placebo children

    10 months

Secondary Outcomes (1)

  • Fecal microbiota profiles of BB536 vs. Placebo children

    10 months

Study Arms (2)

BB536

ACTIVE COMPARATOR

Bifidobacterium longum BB536 (9 log CFU/day) and dextrin

Dietary Supplement: BB536

Placebo

PLACEBO COMPARATOR

100% dextrin

Other: Placebo

Interventions

BB536DIETARY_SUPPLEMENT

Intervention consists of daily administration of 1g probiotic Bifidobacterium longum BB536, administer daily for five days a week at a fixed dosage of 9 log CFU/day for BB536 and continue for 10 months.

Also known as: Bifidobacterium longum BB536
BB536
PlaceboOTHER

Intervention consists of daily administration of 1g of 100% dextrin, administer daily for five days a week and continue for 10 months.

Also known as: 100% dextrin
Placebo

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy male/ female subjects
  • years old
  • BMI within a healthy range (between 5th to 84th percentile according to children BMI-for-age chart)
  • Willing to commit throughout the experiment

You may not qualify if:

  • Type-1 diabetes
  • Long term medication due to certain severe illness
  • HIV/AIDS
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Industrial Technology, Universiti Sains Malaysia

Pulau Pinang, 11900, Malaysia

Location

MeSH Terms

Interventions

Dextrins

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Min Tze Liong, PhD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 5, 2015

Study Start

April 1, 2015

Primary Completion

February 28, 2016

Study Completion

February 28, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

MY(1)