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

RecruitingNAAges 0 Days - 50 YearsAllUniversity of Cape Town
NCT05923333 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 evaluate the effect of B. infantis Rosell®-33 supplementation on: * longitudinal succession of the gut microbiota composition, diversity and function * relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life * stool metabolome * T cell subset ontogeny during the first 9 months of life. Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves: * infant growth * all-cause morbidity * neurodevelopment during the first 9 mo

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📋 Eligibility rules (as published)
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
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What it tests

  • B. infantis Rosell®-33
  • Placebo
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Where

1 site
Khayelitsha Site B Midwife Obstetric Unit
Cape Town, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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