Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04122495 |
| Other study ID # |
USM/JEPEM/19030177 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 29, 2019 |
| Est. completion date |
November 3, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Universiti Sains Malaysia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
