Botswana Diarrheal Diseases Study

This study has been completed.
Sponsor:
Collaborator:
Botswana Ministry of Health
Information provided by (Responsible Party):
Roger Shapiro, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197652
First received: September 12, 2005
Last updated: October 6, 2011
Last verified: October 2011

September 12, 2005
October 6, 2011
March 2001
October 2003   (final data collection date for primary outcome measure)
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00197652 on ClinicalTrials.gov Archive Site
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Botswana Diarrheal Diseases Study
Botswana Diarrheal Diseases Study

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Primary care clinic

HIV Infections
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  • Diarrheal specimens from infants born to HIV infected mothers
    400 diarrheal specimens will suffice to determine the prevalence of specific pathogens in the region. Of these, 300 specimens will be collected from infants born to HIV infected mothers, and 100 specimens will be collected from infants born to HIV uninfected mothers.
  • Breast milk from HIV infected and HIV uninfected women
    Breast milk from HIV infected and HIV uninfected women who are breastfeeding is collected at 2 days, 2 weeks, 2 months, and 5 months post-partum. This breast milk will be compared for in vitro functional quality of immunoglobulins to selected diarrheal and respiratory pathogens.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1350
March 2008
October 2003   (final data collection date for primary outcome measure)

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.
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT00197652
K23 HD001330-05
No
Roger Shapiro, Harvard School of Public Health
Harvard School of Public Health
Botswana Ministry of Health
Principal Investigator: Roger Shapiro, MD Harvard School of Public Health
Harvard School of Public Health
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP