NCT05923333 B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
| NCT ID | NCT05923333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cape Town |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-11 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-08-11 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Heather Jaspan, MD PHD
PRINCIPAL INVESTIGATOR
Seattle Children's Hospital
Frequently Asked Questions
Who can join the NCT05923333 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 50 Years, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05923333 currently recruiting?
Yes, NCT05923333 is actively recruiting participants. Contact the research team at hbjaspan@gmail.com for enrollment information.
Where is the NCT05923333 trial being conducted?
This trial is being conducted at Cape Town, South Africa.
Who is sponsoring the NCT05923333 clinical trial?
NCT05923333 is sponsored by University of Cape Town. The principal investigator is Heather Jaspan, MD PHD at Seattle Children's Hospital. The trial plans to enroll 200 participants.
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