Status:
RECRUITING
B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Seattle Children's Hospital
University of Stellenbosch
Conditions:
Hiv
Vaccine Reaction
Eligibility:
All Genders
0-50 years
Phase:
NA
Brief Summary
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 week...
Detailed Description
Infants who are born to mothers with HIV (exposed but uninfected; iHEU) are at higher risk of morbidity and display multiple immune alterations compared to infants who are HIV-unexposed (iHU). Easily ...
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 months of life
Inclusion Criteria Infant:
- Documented HIV seronegative at birth
- Born at term (completed at least 37 weeks of gestation)
- Birth weight >2.4kgs
Exclusion Criteria:
- Severe illnesses, e.g. Sepsis
- current TB or known household TB contact
- Chronic disorder or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that in the opinion of the investigator would alter immunity
- Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections
- Known contraindications to components of the interventional products
- Taking additional probiotics or prebiotics
- Any condition that in the opinion of the investigator would make participation in the trial unsafe
Key Trial Info
Start Date :
August 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05923333
Start Date
August 11 2023
End Date
June 1 2027
Last Update
August 22 2024
Active Locations (1)
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1
Khayelitsha Site B Midwife Obstetric Unit
Cape Town, South Africa