Status:
COMPLETED
Safety and Efficacy of Probiotics in Bangladeshi Infants
Lead Sponsor:
Stanford University
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Thrasher Research Fund
Conditions:
Healthy
Eligibility:
All Genders
1-3 years
Phase:
PHASE1
Brief Summary
Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that ...
Eligibility Criteria
Inclusion
- Healthy infants.
- Infants 1 -3 months of age at the beginning of the study.
- Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
- Parents and child are planning to remain in Dhaka for the next four months.
Exclusion
- Infants with known birth defects.
- Infants who have been hospitalized.
- Infants who have an acute infection or illness at the time of enrolment.
- Infants who are currently taking antibiotics
- Infants \<1 month of age or \>3 months of age.
- Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
- Infants who are already receiving a probiotic product or treatment.
- A diagnosis or suspicion of immunodeficiency disorder.
- A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
- Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01899378
Start Date
October 1 2013
End Date
July 1 2014
Last Update
October 17 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
International Center for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh