B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
Recruiting
N/A
Interventional Study
Hiv
Vaccine Reaction
Microbial Colonization
Infant Development
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 0 Days – 50
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- University of Cape Town · Other
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About This Trial
The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on:
* gut microbiome composition and diversity at 4 weeks of life
* markers of intestinal inflammation and microbial translocation at 4 weeks of life
* Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life
The secondary objectives include to evalu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria Mother:
* Willing and able to provide signed and dated informed consent form
* 18 years of age or older
* Documented HIV seropositive
* Antiretroviral therapy initiated before the third trimester of pregnancy
* Planning on exclusively breastfeeding the infant for the first 6 mont…
Contacts