Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
Condition: Respiratory Infection (for Example, Pneumonia, Bronchitis)
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Bronchitis
Study type: Interventional

Summary: 
      This project aims to study the benefits of probiotics namely Bifidobacterium lactis M8 in
      treatment of upper and lower respiratory tract infections in young children, which are found
      common among children in Malaysia aged from 0-24 months.
    

Detailed description: 
      Respiratory illnesses are the most common acute diseases in children where no virtually
      effective treatments or prophylaxes are available for these infections. Probiotics on the
      other hand have gained increasing evidences as an effective therapy in preventing respiratory
      tract infections. While the precise mechanisms of using probiotics in management of
      respiratory infections are largely unknown, speculations include: probiotics compete against
      pathogens; increase the barrier function in respiratory epithelium; immunostimulatory effects
      by enhancing cellular immunity with increased activity of natural killer cells and
      macrophages in airways. Hence, probiotics may offer safe means of reducing the risk of early
      respiratory related illnesses, common cold and antibiotic use, and the risk of recurrent
      respiratory infections, thereby represent a simple, safe, effective, available and affordable
      method for preventing respiratory infections in children.

      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.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks; Oral administration of maltodextrin daily for 4-weeks
Other intervention name(s): Bifidobacterium lactis M8
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: probiotic; respiratory tract infections; Bifidobacterium; children