Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
NCT ID: NCT04122495
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-08-29
2020-11-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic
Bifidobacterium lactis M8 at 10 log CFU/day for 4 weeks
Probiotic
Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks
Placebo
Intervention consists of daily administration of 1g of maltodextrin, administered daily for 4-weeks
Placebo
Oral administration of maltodextrin daily for 4-weeks
Interventions
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Probiotic
Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks
Placebo
Oral administration of maltodextrin daily for 4-weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to commit throughout the experiment
Exclusion Criteria
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
1 Month
24 Months
ALL
No
Sponsors
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Beijing Scitop Bio-Tech Shareholding Co.Ltd.
UNKNOWN
Universiti Sains Malaysia
OTHER
Responsible Party
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Min-Tze LIONG
Prof. (Clinical Professor)
Principal Investigators
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Min Tze Liong, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Sains Malaysia
Locations
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Hospital USM
Kubang Kerian, Kelantan, Malaysia
Countries
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References
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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.
Other Identifiers
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USM/JEPEM/19030177
Identifier Type: -
Identifier Source: org_study_id
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