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