Effect of Probiotics (Bio-Three) in Children's Enterocolitis
Primary Purpose
Diarrhea, Enteritis, Enterocolitis
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Biothree
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Probiotics, Diarrhea, Enterocolitis
Eligibility 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
Sites / Locations
- Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital
Outcomes
Primary Outcome Measures
Clinical symptom 2 days after medication
Microbiology study 3 days and one week after medication
Secondary Outcome Measures
Full Information
NCT ID
NCT00463190
First Posted
April 18, 2007
Last Updated
September 18, 2008
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00463190
Brief Title
Effect of Probiotics (Bio-Three) in Children's Enterocolitis
Official Title
Postmarketing Study of Probiotics Medication in Childhood Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Enteritis, Enterocolitis
Keywords
Probiotics, Diarrhea, Enterocolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Biothree
Primary Outcome Measure Information:
Title
Clinical symptom 2 days after medication
Title
Microbiology study 3 days and one week after medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Chang Chen, MD
Organizational Affiliation
Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
16124337
Citation
Chen CC, Walker WA. Probiotics and prebiotics: role in clinical disease states. Adv Pediatr. 2005;52:77-113. doi: 10.1016/j.yapd.2005.03.001.
Results Reference
background
PubMed Identifier
20135748
Citation
Chen CC, Kong MS, Lai MW, Chao HC, Chang KW, Chen SY, Huang YC, Chiu CH, Li WC, Lin PY, Chen CJ, Li TY. Probiotics have clinical, microbiologic, and immunologic efficacy in acute infectious diarrhea. Pediatr Infect Dis J. 2010 Feb;29(2):135-8. doi: 10.1097/inf.0b013e3181b530bf.
Results Reference
derived
Links:
URL
http://www.cgmh.org.tw/
Description
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Effect of Probiotics (Bio-Three) in Children's Enterocolitis
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