RecruitingNot Applicable

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

South Africa200 participantsStarted 2023-08-11

Plain-language 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 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 months of life * antibody responses to early childhood vaccines

Who can participate

Age range0 Days – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Gut microbiome

Timeframe: 4 weeks of age

Markers of intestinal inflammation and microbial translocation

Timeframe: 4 - 36 weeks of age

BCG vaccine respone

Timeframe: 7 weeks of age

BCG vaccine respone

Timeframe: 36 weeks of age

Trial details

NCT IDNCT05923333

SponsorUniversity of Cape Town

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Heather Jaspan, MD PHD

2068543336 hbjaspan@gmail.com