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Completed

NCT Number: NCT00463190

Effect of Probiotics (Bio-Three) in Children's Enterocolitis

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.

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Key information

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical symptom of diarrhea less than 3 days

Exclusion criteria

  • Severe abdominal distension with risk of bowel perforation
  • Risk for sepsis
  • Past history with surgical operation of gastrointestinal tracts

Treatment and study plan

Biothree

Drug

Primary outcomes

  1. Clinical symptom 2 days after medication

  2. Microbiology study 3 days and one week after medication

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Postmarketing Study of Probiotics Medication in Childhood Diarrhea

Important dates

Study start
2006
Study completion
2007
First posted
Apr 20, 2007
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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