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Official title B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
ClinicalTrials.gov ID: NCT05923333
What this study is testing
- What it's testing
- 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.
- Time commitment: about 36 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections
- Known contraindications to components of the treatment products
- Taking additional probiotics or prebiotics
See the full eligibility 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 Infant:
- Documented HIV seronegative at birth
- Born at term (completed at least 37 weeks of gestation)
- Birth weight \>2.4kgs
- 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 treatment products
- Taking additional probiotics or prebiotics
- Any condition that in the opinion of the investigator would make participation in the trial unsafe
The study team makes the final eligibility decision.
Where it's taking place
- Cape Town, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cape Town, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.