This trial is active, not recruiting.

Conditions hiv, malnutrition, cryptosporidiosis
Sponsor Cornell University
Start date April 2012
End date July 2013
Trial size 208 participants
Trial identifier NCT01699841, IRB 1111002616


The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Breast milk composition
time frame: Up to 6 months post-partum

Secondary Outcomes

Infant anthropometric measures
time frame: Up to 6 months of age
Infant infectious disease events
time frame: Up to 6 months of age

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Informed consent provided by mothers, and parental consent on behalf of their infants - Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative) - Stated intention to remain in the clinic catchment area ≥6 months post-partum - Singleton birth Exclusion Criteria: - None

Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Cornell University.