Effects of Bifidobacterium Longum BB536 on Incidence of Acute Diarrhea and/or Respiratory- Related Illnesses in Children
NCT ID: NCT02434042
Last Updated: 2017-11-06
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
520 participants
INTERVENTIONAL
2015-04-01
2016-02-28
Brief Summary
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Detailed Description
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Probiotics are preparations of bacteria and yeasts that are considered to confer a beneficial health effect when taken in an adequate amount. Bifidobacterium longum BB536, is a probiotic with over 100 scientific publications based on in vitro, in vivo, and clinical studies, with long consumption history supporting safety and health benefits.
BB536 is also commercially available in Malaysia and Japan in the form of food supplement and health supplements. Some of these include health supplements for children such as MAXBIOTICS, KidsBiotics and JANIPRO BB-G. All these three brands are sold in Malaysia and they all contain mixture of raw ingredient Bifidobacterium longum BB536 manufactured by Morinaga Milk Industry Co., Ltd. and other probiotic strains. In this study, the investigational product, Bifidobacterium longum BB536 and placebo is manufactured by Morinaga Milk Industry Co. Ltd., Japan.
Morinaga BB536 had been awarded FOSHU (Food for Specified Health Uses) status by Japan's Ministry of Health, Labour and Welfare. This status is granted to food products that have been shown in human clinical studies to demonstrate specific health benefits. Also, in year 2007, BB536 had obtained GRAS (Generally Recognised As Safe) certification in USA by FDA. BB536 has confirmed its safety for consumption as it is made in HACCP certified manufacturing plant (Pacific Resources, 2012). BB536 does not contain any porcine or bovine ingredients and has obtained the HALAL certification from the Japan Muslim Association (JMA), Japan. JMA is recognized by JAKIM, Malaysia.
Morinaga B. longum BB536 has been the subject of extensive clinical research and technical development with evidences from more than 100 scientific publications. There are no side effects been reported from the consumption of BB536 including premature infants, pregnant women, elderly people and patients who are taking immunosuppressive drugs. Based on in vitro, in vivo, and clinical studies, long consumption history (more than 30 years) support the safety and health benefits of the strain BB536 by improving intestinal environment, prevention of diarrhea, alleviation of constipation as well as supporting immune system. Based on previous study, ingestion of yogurt fortified with B. longum BB536 can help to reduce 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. There was also clinical trial done on infants in Hidaka General Hospital through the administration of lyophilized powder containing B. longum BB536 and B. breve M-16V each at 9 log cfu/sachet. Such findings suggest that B. longum BB536 is safe and could be used further to evaluate its effect in preventing diarrhea and/or respiratory-related illness prevalence in children from daycare centres.
A total number of five hundred and twenty (520) healthy children from age 2-6 years old will be recruited for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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BB536
Bifidobacterium longum BB536 (9 log CFU/day) and dextrin
BB536
Intervention consists of daily administration of 1g probiotic Bifidobacterium longum BB536, administer daily for five days a week at a fixed dosage of 9 log CFU/day for BB536 and continue for 10 months.
Placebo
100% dextrin
Placebo
Intervention consists of daily administration of 1g of 100% dextrin, administer daily for five days a week and continue for 10 months.
Interventions
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BB536
Intervention consists of daily administration of 1g probiotic Bifidobacterium longum BB536, administer daily for five days a week at a fixed dosage of 9 log CFU/day for BB536 and continue for 10 months.
Placebo
Intervention consists of daily administration of 1g of 100% dextrin, administer daily for five days a week and continue for 10 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2-6 years old
* BMI within a healthy range (between 5th to 84th percentile according to children BMI-for-age chart)
* Willing to commit throughout the experiment
Exclusion Criteria
* Long term medication due to certain severe illness
* HIV/AIDS
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
2 Years
6 Years
ALL
Yes
Sponsors
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Morinaga Milk Industry Co., LTD
INDUSTRY
Universiti Sains Malaysia
OTHER
Responsible Party
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Min-Tze LIONG
Associate Professor Dr
Principal Investigators
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Min Tze Liong, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Sains Malaysia
Locations
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School of Industrial Technology, Universiti Sains Malaysia
Pulau Pinang, , Malaysia
Countries
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Other Identifiers
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304/PTEKIND/650689
Identifier Type: -
Identifier Source: org_study_id