B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

Launched by UNIVERSITY OF CAPE TOWN · Jun 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether giving a specific probiotic called B. infantis Rosell®-33 to infants who are exposed to HIV can help improve their immune system and gut health. The researchers want to see how this probiotic affects the balance of good bacteria in the babies' guts, inflammation levels, and their immune responses to vaccines as they grow. They will also look at how the babies grow and develop over the first nine months of life, including their ability to fight infections and respond to vaccinations.

To participate in this study, mothers need to be at least 18 years old, HIV-positive, and planning to exclusively breastfeed their infants for the first six months. The babies must be HIV-negative, born at full term, and weigh more than 2.4 kilograms at birth. Participants will have regular check-ups to monitor the babies’ health and development, and all necessary care will be provided throughout the study. This trial is currently recruiting participants and aims to better understand how early probiotic supplementation can support the health of infants exposed to HIV.

Gender

ALL

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