Who is sponsoring NCT04122495?

NCT04122495 is sponsored by Universiti Sains Malaysia.

What drugs are being tested in NCT04122495?

Interventions in NCT04122495: Probiotic, Placebo.

What condition does NCT04122495 study?

NCT04122495 studies Respiratory Infection (for Example, Pneumonia, Bronchitis).

Is NCT04122495 still recruiting?

NCT04122495 is currently completed. Last updated 29 April 2021.

Last reviewed 2021-04-29 · How we verify

NCT04122495

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic

Completed NA Last updated 29 April 2021

What this trial tests

NA trial testing Probiotic in Respiratory Infection (for Example, Pneumonia, Bronchitis) in 120 participants. Completed in 3 November 2020.

Timeline

29 August 2019

Primary endpoint
3 November 2020

3 November 2020

Quick facts

Lead sponsor	Universiti Sains Malaysia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	120
Start date	29 August 2019
Primary completion	3 November 2020
Estimated completion	3 November 2020
Sites	1 location across Malaysia

Drugs / interventions tested

Probiotic
Placebo

Conditions studied

Respiratory Infection (for Example, Pneumonia, Bronchitis) — all drugs for Respiratory Infection (for Example, Pneumonia, Bronchitis) →

Sponsor

Universiti Sains Malaysia — full company profile →

Who can join

Adults 1 Month to 24 Months, any sex, with Respiratory Infection (for Example, Pneumonia, Bronchitis). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Mageswary MU, Ang XY, Lee BK, Chung YF, et al · · 2022 · cited 20× · PMID 34825264 · DOI 10.1007/s00394-021-02689-8
Bacterial live therapeutics for human diseases.
Frutos-Grilo E, Ana Y, Gonzalez-de Miguel J, Cardona-I-Collado M, et al · · 2024 · cited 6× · PMID 39443745 · DOI 10.1038/s44320-024-00067-0

Verify or expand the search:

Other trials of Probiotic

Trials testing the same drug.

NCT07529457 — Akk09 in Adults With Constipation · NA · not yet recruiting
NCT07507955 — Probiotics for Constipation Relief in Adults · NA · not yet recruiting
NCT07462481 — Probiotic Improve Constipation · NA · recruiting
NCT07511855 — Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term T · Phase 2 · not yet recruiting
NCT07474064 — Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC · Phase 2 · not yet recruiting

Other recruiting trials for Respiratory Infection (for Example, Pneumonia, Bronchitis)

Currently open trials in the same condition.

NCT07334795 — Intermountain Stewardship in Community Outpatient Settings-Resources & Engagement-Pediatrics · active not recruiting
NCT05794815 — Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms · NA · recruiting

Other Universiti Sains Malaysia trials

Trials by the same sponsor.

NCT07397104 — Validity of a Self-reported Questionnaire for Periodontal Status in a Saudi Population · not yet recruiting
NCT07279324 — Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease · NA · not yet recruiting
NCT07338045 — The Effects of Eight-Week Baduanjin Exercise on Chronic Low Back Pain and Disability Among Office Workers. · NA · not yet recruiting
NCT07410351 — Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi · not yet recruiting
NCT07448909 — Cognitive-Frailty Gait Biomechanics for Early Dementia Detection · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04122495 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universiti Sains Malaysia
Last refreshed: 29 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04122495.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing