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

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ClinicalTrials.gov Identifier: NCT00463190
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : September 19, 2008
Sponsor:
Information provided by:
Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Diarrhea Enteritis Enterocolitis Drug: Biothree Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Postmarketing Study of Probiotics Medication in Childhood Diarrhea
Study Start Date : February 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical symptom 2 days after medication
  2. Microbiology study 3 days and one week after medication


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463190


Locations
Taiwan
Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chien-Chang Chen, MD Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00463190     History of Changes
Other Study ID Numbers: X-BIO-440021
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: April 2007

Keywords provided by Chang Gung Memorial Hospital:
Probiotics
Diarrhea
Enterocolitis

Additional relevant MeSH terms:
Diarrhea
Enterocolitis
Enteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases