B. Infantis to Boost Immunity in Infants Exposed to HIV
Official title: Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial
Run by University of Cape Town · NCT05923333 · Data updated 2026-11-12
This study is testing if giving a probiotic to infants born to HIV-positive mothers can help boost their immunity and improve their gut health during the first few months of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 50 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Cape Town Academic / other |
| Locations | 1 site (Cape Town) |
| Status | Recruiting |
| Started | August 11, 2023 |
| Main results expected | June 2026 |
| Study ends | June 2027 |
| Registry record updated | August 22, 2024 |
| Trial ID | NCT05923333 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include infants born to HIV-positive mothers who are HIV-negative at birth and are planning to be exclusively breastfed.
✕Probably not a fit
Patients who may not benefit include those with severe illnesses or chronic disorders that could affect immunity.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of B. infantis Rosell®-33 supplementation on infants born to HIV-positive mothers. It aims to assess changes in gut microbiome composition, intestinal inflammation markers, and immune responses to vaccines over the first 36 weeks of life. The study involves a randomized, controlled design where 200 breastfed infants will receive either the probiotic or a placebo for the first month. Participants will be monitored for growth, morbidity, and neurodevelopmental outcomes.
Why it matters
Potential benefit: If successful, this intervention could enhance immune function and overall health outcomes in infants exposed to HIV.
How similar studies have gone: Other studies have shown promising results with probiotic supplementation in improving gut health and immune responses, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Khayelitsha Site B Midwife Obstetric Unit
Cape Town, South Africa Recruiting
Study contacts
- Principal investigator: Heather Jaspan, MD PHD — Seattle Children's Hospital
- Study coordinator: Heather Jaspan, MD PHD
- Email: hbjaspan@gmail.com
- Phone: 2068543336
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.