Effect of Probiotics (Bio-Three) in Children's Enterocolitis
Condition: Diarrhea; Enteritis; Enterocolitis
MeSH terms: Enterocolitis; Enteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Probiotic bacteria inhabit the gastrointestinal tracts of healthy individuals and may improve
      the health status of patients with digestive disease. The first aim of our study will seek to
      determine if probiotics medication (Bio-Three) inhibit gastrointestinal infection and reduce
      its inflammatory response in the intestine. The second aim will explore the bacterial count
      (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in
      children. We try to seek to gain an advanced understanding of probiotics versus pathogenic
      microorganism and host interactions, and mucosal immune responses to probiotics in the
      intestine.
    

Detailed description: 
      Viral infection is a leading cause of diarrhea in childhood . Rotavirus is the most common
      virus cause diarrhea among children worldwide. Probiotics are considered to be beneficial in
      the management and prevention of viral diarrhea. Saavedra et al. had reported that feeding an
      infant formula with Streptococcus thermophilus and Bifidobacterium bifidum can reduce the
      incidence of diarrhea and rotavirus shedding in infants. Another study suggests that children
      receiving a bifidobacteria-supplemented milk-based formula may be protective against
      symptomatic rotavirus infection.

      Several pathogens, such as Salmonella spp., enteropathogenic Escherichia coli and
      enterohemorrhagic E. coli spp., Campylobacter spp., Shigella spp., can cause invasive
      diarrhea. These pathogens have the capacity to invade the mucosa of the distal small
      intestine and colon, stimulate local and systemic inflammatory responses, and sometimes
      causing hemorrhage and ulceration of the mucosa. Some strains of invasive bacteria not only
      induce intestinal cellular damage but also enter the systemic circulation to affect distal
      organs. Probiotics have been shown to be effective in the treatment of these conditions.
      There are many mechanisms by which probiotics enhance intestinal health, including
      stimulation of immunity, competition for limited nutrients, inhibition of epithelial and
      mucosal adherence, inhibition of epithelial invasion and production of antimicrobial
      substances .

      Clostridium butyricum is effective for both the treatment and the prophylaxis of
      antibiotic-associated diarrhea in children, as it normalizes the intestinal flora disturbed
      by antibiotics. Probiotics ( Bacillus mesentericus) affect intestinal bacterial flora by
      increasing anaerobic bacteria and decreasing the population of potentially pathogenic
      microorganisms. A decrease in luminal endotoxin may result in less endotoxin translocation or
      bacterial translocation. The effect of Bio-Three (Enterococcus T-110, C. butyricum TO-A, B.
      mesentericus TO-A) was ever proved on (a) normalization of enterobacterial flora, (b)
      improvement of growing abilities of live bacteria in the drug, (c) inhibition of pathogenic
      bacteria , (d) promotion of the growth of beneficial bacteria . Despite the gastrointestinal
      effect, Bio-three therapy was also effective in both clinical and bacteriological responses
      in genital tract infection by published literature.
    

Intervention name(s): Biothree
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Probiotics; Diarrhea; Enterocolitis