Diarrhea Clinical Trial
Official title:
Postmarketing Study of Probiotics Medication in Childhood Diarrhea
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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