NCT04122495

Brief Summary

This project aims to study the benefits of probiotics namely Bifidobacterium lactis M8 in treatment of upper and lower respiratory tract infections in young children, which are found common among children in Malaysia aged from 0-24 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

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

August 29, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

September 30, 2019

Last Update Submit

April 26, 2021

Conditions

Respiratory Infection (for Example, Pneumonia, Bronchitis)

Keywords

probioticrespiratory tract infectionsBifidobacteriumchildren

Outcome Measures

Primary Outcomes (1)

  • Duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8

    Differences in duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8 at 10 log CFU/day compared to placebo

    4-weeks

Secondary Outcomes (5)

  • Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042).

    4-weeks

  • Clinical symptoms in young children with respiratory tract infections upon administration of B. lactis M8 as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042).

    4-weeks

  • Microbiota profiles of saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via pyrosequencing

    4-weeks

  • Concentrations of proteins in saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via biochemical tests

    4-weeks

  • Gene expressions for inflammation and immunity from saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via real time PCR

    4-weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Bifidobacterium lactis M8 at 10 log CFU/day for 4 weeks

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Intervention consists of daily administration of 1g of maltodextrin, administered daily for 4-weeks

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks

Also known as: Bifidobacterium lactis M8
Probiotic
PlaceboDIETARY_SUPPLEMENT

Oral administration of maltodextrin daily for 4-weeks

Placebo

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • young children aged 1-24 month, admitted to hospital for having respiratory diseases.
  • Willing to commit throughout the experiment

You may not qualify if:

  • Long term medication due to certain severe illness
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital USM

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (1)

  • Mageswary MU, Ang XY, Lee BK, Chung YF, Azhar SNA, Hamid IJA, Bakar HA, Roslan NS, Liu X, Kang X, Dai L, Sreenivasan S, Taib F, Zhang H, Liong MT. Probiotic Bifidobacterium lactis Probio-M8 treated and prevented acute RTI, reduced antibiotic use and hospital stay in hospitalized young children: a randomized, double-blind, placebo-controlled study. Eur J Nutr. 2022 Apr;61(3):1679-1691. doi: 10.1007/s00394-021-02689-8. Epub 2021 Nov 26.

    PMID: 34825264DERIVED

MeSH Terms

Conditions

Respiratory Tract InfectionsPneumoniaBronchitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesLung DiseasesBronchial DiseasesLung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. (Clinical Professor)

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 10, 2019

Study Start

August 29, 2019

Primary Completion

November 3, 2020

Study Completion

November 3, 2020

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

MY(1)