B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-50
SponsorUniversity of Cape Town
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- B. infantis Rosell®-33
- Placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Cape Town
Lead sponsor
Seattle Children's Hospital
Collaborator
University of Stellenbosch
Collaborator
Institute for Systems Biology
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov