Effects of Probiotic Against Respiratory & Gastrointestinal Illnesses in Children
NCT ID: NCT05734417
Last Updated: 2023-10-04
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2023-05-01
2025-03-01
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.
Probiotic (Bifidobacterium lactis subsp. infantis B8762) adheres to probiotic properties such as excellent tolerance to gastric acid, intestinal fluid and bile salt of the digestive system. Both probiotic and placebo products are manufactured under an ISO9001, ISO22000 and HACCP conditions. All products do not contain any animal-origin ingredients. The probiotic product contains probiotic and carrier while placebo contains only carrier. Sachets of products containing probiotic and placebo appear as light yellow powder. Both probiotic and placebo products are kept at storage temperature range below 30oC according to the condition recommended by the manufacturer.
A total number of 120 pre-school children with respiratory diseases aged below 7-years 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
Intervention consists of daily administration of excipient plus Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day administered daily for 4-weeks
Probiotic
Oral administration of Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day for 4-weeks
Placebo
Intervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks
Placebo
Intervention consists of daily administration of 2g/sachet of excipient administered daily for 4-weeks
Interventions
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Probiotic
Oral administration of Bifidobacterium lactis subsp. infantis B8762 at 0.5x10 log colony forming unit (CFU)/day for 4-weeks
Placebo
Intervention consists of daily administration of 2g/sachet of excipient administered 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
84 Months
ALL
No
Sponsors
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International Islamic University Malaysia
OTHER
Beijing Scitop Bio-Tech Co., Ltd.
UNKNOWN
Min-Tze LIONG
OTHER
Responsible Party
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Min-Tze LIONG
Professor
Principal Investigators
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Taufiq Hidayat Hasan, MBBS
Role: PRINCIPAL_INVESTIGATOR
International Islamic University Malaysia
Locations
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Department of Paediatrics, Kulliyyah of Medicine, IIUM Medical Centre, International Islamic University Malaysia
Kuantan, Pahang, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIUM-2022-193: UKM-2023-603
Identifier Type: -
Identifier Source: org_study_id
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