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Safety and Efficacy of Probiotics in Bangladeshi Infants
Not Recruiting
Trial ID: NCT01899378
Purpose
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 two probiotics are safe for infants in Bangladesh and may have
an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i)
to confirm the safety of administering probiotic strains to infants in low-income countries,
ii) to determine the effects of dosing frequency on colonization and persistence of
probiotics in the GI tract, iii) to measure markers of intestinal and immune function and
microbiota structure.
Official Title
Safety and Efficacy of Probiotics in Bangladeshi Infants
Stanford Investigator(s)
Julie Parsonnet
George DeForest Barnett Professor of Medicine and Professor of Epidemiology and Population Health
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.
Intervention(s):
dietary supplement: Lactobacillus reuteri DSM 17938
dietary supplement: Bifidobacterium longum infantis
dietary supplement: Lactobacillus reuteri DSM 17938
dietary supplement: Bifidobacterium longum infantis
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305