Safety and Efficacy of Probiotics in Bangladeshi Infants

Trial ID or NCT#

NCT01899378

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 1 Month to 3 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * 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:
  1. * 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.
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Investigator(s)

Julie Parsonnet
Julie Parsonnet
Infectious diseases doctor
George DeForest Barnett Professor of Medicine and Professor of Epidemiology and Population Health
Stephen Luby

View on ClinicalTrials.gov