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Botswana Diarrheal Diseases Study

Botswana Diarrheal Diseases Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00197652
Enrollment
1350
Registered
2005-09-20
Start date
2001-03-31
Completion date
2008-03-31
Last updated
2011-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Prevention of Mother-Infant HIV Transmission

Brief summary

The goals of this study are to: 1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers. * analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers. * comparison to rates among infants born to HIV uninfected mothers. 2. link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.

Interventions

None listed

Sponsors

Botswana Ministry of Health
CollaboratorOTHER_GOV
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Subject is able to provide independent informed consent. * Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly. * Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days. For HIV-infected subjects: * Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.

Exclusion criteria

* Subject cannot provide legal independent informed consent.

Design outcomes

Primary

MeasureTime frame
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE24 months

Countries

Botswana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026