Actively Recruiting
B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
Led by University of Cape Town · Updated on 2024-08-22
200
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
U
University of Cape Town
Lead Sponsor
S
Seattle Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother willing and able to provide signed and dated informed consent form
- Mother 18 years of age or older
- Mother documented HIV seropositive
- Mother started antiretroviral therapy before the third trimester of pregnancy
- Mother plans to exclusively breastfeed infant for the first 6 months
- Infant documented HIV seronegative at birth
- Infant born at term (at least 37 weeks gestation)
- Infant birth weight greater than 2.4 kilograms
You will not qualify if you...
- Severe illnesses such as sepsis
- Current tuberculosis or known household tuberculosis contact
- Chronic disorders or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that might alter immunity
- Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies, or congenital infections
- Known allergies or contraindications to components of the study products
- Taking additional probiotics or prebiotics
- Any condition making participation unsafe according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Khayelitsha Site B Midwife Obstetric Unit
Cape Town, South Africa
Actively Recruiting
Research Team
H
Heather Jaspan, MD PHD
CONTACT
A
Anna-Ursula Happel, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here