Healthy Volunteers Clinical Trial
Official title:
Study on Oral Administration of Bifidobacterium Longum BB536 on Incidence of Acute Diarrhea and/or Respiratory- Related Illnesses Compared to Placebo
This project aims to study the benefits of probiotics namely Bifidobacterium longum BB536 in prevention of acute diarrhea and/or respiratory-related illnesses, which are found common among children in Malaysia aged from 2 to 6 years.
Data from WHO revealed that 5.2 million of children under five of age die every year due to
preventable disease such as diarrhea, malaria and pneumonia. In Malaysia, reported cases of
diarrhea and acute gastroenteritis have been observed to occur throughout the year, with
rotavirus-associated diarrhea being the most prevalently identified gastrointestinal
disorder.
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.
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