Effects of Bifidobacterium Longum BB536 on Incidence of Acute Diarrhea and/or Respiratory- Related Illnesses in Children
Condition: Healthy Volunteers
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): BB536; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; Intervention consists of daily administration of 1g of 100% dextrin, administer daily for five days a week and continue for 10 months.
Other intervention name(s): Bifidobacterium longum BB536; 100% dextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: probiotic; children; gastrointestinal; upper respiratory