Clinical trial NCT04122495: Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
Official title: Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infection (for Example, Pneumonia, Bronchitis)
Keywords: probiotic
respiratory tract infections
Bifidobacterium
children
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Beijing Scitop Bio-Tech Shareholding Co.Ltd.
First posted: 2019-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Respiratory illnesses are the most common acute diseases in children where no virtually effective treatments or prophylaxes are available for these infections. Probiotics on the other hand have gained increasing evidences as an effective therapy in preventing respiratory tract infections. While the precise mechanisms of using probiotics in management of respiratory infections are largely unknown, speculations include: probiotics compete against pathogens; increase the barrier function in respiratory epithelium; immunostimulatory effects by enhancing cellular immunity with increased activity of natural killer cells and macrophages in airways. Hence, probiotics may offer safe means of reducing the risk of early respiratory related illnesses, common cold and antibiotic use, and the risk of recurrent respiratory infections, thereby represent a simple, safe, effective, available and affordable method for preventing respiratory infections in children.

Among the various types of probiotics, Bifidobacterium is one of the best-known probiotic genus in the world, and it is widely applied in the dairy industry as a probiotic. Evidences from more than 100 scientific publications based on in vitro, in vivo, and clinical studies and long consumption history support the safety and health benefits of Bifidobacterium strains. The ingestion of yogurt fortified with B. longum reduced harmful bacteria such as Enterobacteriaceae, Streptococcus and C. perfringens, while at the same time alter the microbiota gut profile of volunteers with a significant increase of beneficial microbes Bifidobacterium and Lactobacillus species. Additionally, putrefactive substances in the intestinal environment were also reduced in the presence of the probiotic supplement. Such findings suggest that Bifidobacterium strains are safe and could be used further to evaluate its effect in preventing diarrhea and/or respiratory-related illness prevalence in young children.

Bifidobacterium lactis M8 was isolated from breast milk samples collected from healthy woman in China. M8 was selected as it was the best among 857 other strains with excellent tolerance to gastric acid, intestinal fluid and bile salt of the digestive system. M8 is manufactured under a ISO9001 and ISO22000 certified manufacturing plant (JinHua YinHe Biological Technology Co. Ltd., China). M8 does not contain any porcine or bovine ingredients and has obtained the HALAL certification from ARA HALAL Development Services Center Inc. (ARA), which is recognized by JAKIM, Malaysia.

M8 is incorporated and sold in the market of China, Taiwan and Singapore in a variety of products, ranging from dairy (yoghurt and fermented milk). The product M8 contains good bacteria Bifidobacterium lactis M8 and primarily maltodextrin as carrier while placebo contains primarily maltodextrin. Sachets of products containing probiotic M8 and placebo appear as light yellow powder. Both M8 and placebo products are kept at storage temperature range below 30oC according to the condition recommended by the manufacturer.

A total number of 120 respiratory-related hospitalized children from age 0-24 months old will be recruited for this study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Duration of hospitalization in young children with respiratory tract infections upon administration of B. lactis M8
timeFrame: 4-weeks
Secondary outcomes:
measure: 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).
timeFrame: 4-weeks
measure: 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).
timeFrame: 4-weeks
measure: Microbiota profiles of saliva and fecal samples in young children with respiratory tract infections upon administration of B. lactis M8 as assessed via pyrosequencing
timeFrame: 4-weeks
measure: 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
timeFrame: 4-weeks
measure: 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
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Hospital USM
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Min Tze Liong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.