Effect of Probiotics (Bio-Three) in Children's Enterocolitis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00463190 |
|
Recruitment Status :
Completed
First Posted : April 20, 2007
Last Update Posted : September 19, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diarrhea Enteritis Enterocolitis | Drug: Biothree | Phase 4 |
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 |
- Clinical symptom 2 days after medication
- Microbiology study 3 days and one week after medication
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Taiwan | |
| Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital | |
| Taoyuan, Taiwan, 333 | |
| 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 |