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 range

0 Days – 50 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Hiv trials