Status:
TERMINATED
Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Diarrhea
Eligibility:
MALE
6-24 years
Phase:
NA
Brief Summary
This study hopes to demonstrate the potentials of a new form of therapy for childhood diarrhea, a major cause of morbidity and deaths in Bangladesh and other developing countries, and thus a priority ...
Detailed Description
This randomized double-blind, placebo controlled trial (RCT) aims to evaluate the effect of oral administered E. coli phage in children aged 4-60 months of age with proven ETEC and EPEC diarrhea. Chil...
Eligibility Criteria
Inclusion
- Sex: male
- Age: 6 - 24 months
- Better nourished (weight for age \> 60 NCHS median)
- H/o. diarrhea of less than 48 hours
- Written informed consent from either parents/guardian (thumb impression for those who are not literate) for children
- Negative test results for dark field microscopy of Vibrio cholerae and ELISA test for rotavirus in initial stool samples
Exclusion
- Systemic infection requiring antibiotic treatment
- Severe malnutrition (W/A \< 60%)
- Unwilling to comply with study procedures
- Currently participating or have participated in another clinical trial within the last 4 weeks at screening
- Clinically significant abnormalities from medical history, physical examination, vital signs, haematology, clinical chemistry results, or other laboratory abnormalities
- Clinically suggestive of invasive diarrhea
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00937274
Start Date
August 1 2009
End Date
January 1 2013
Last Update
November 13 2013
Active Locations (1)
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1
Clinical Sciences Division, ICDDR,B, Mohakhali,
Dhaka, Bangladesh, 1212