An interventional study of B. infantis Rosell®-33 and Placebo in Hiv, Vaccine Reaction and Microbial Colonization, sponsored by University of Cape Town. Recruiting at 1 site in South Africa. Open to participants aged 0 Days to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by University of Cape Town · Not applicable, Interventional, and Treatment
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:
The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on:
Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves:
Infants who are born to mothers with HIV (exposed but uninfected; iHEU) are at higher risk of morbidity and display multiple immune alterations compared to infants who are HIV-unexposed (iHU). Easily implementable strategies to improve immunity of iHEU, and possibly subsequent health outcomes, are needed. iHEU have altered gut microbiome composition and bifidobacterial depletion, and relative abundance of Bifidobacterium infantis has been associated with immune ontogeny, including humoral and cellular vaccine responses. Therefore, a randomized trial of B. infantis Rosell®-33 versus placebo given during the first month of life in South African iHEU will be conducted.
This is a parallel, randomised, controlled study. Two-hundred breastfed iHEU will be enrolled from the Khayelitsha Site B Midwife Obstetric Unit in Cape Town, South Africa and 1:1 randomised to receive 8 x109 CFU B. infantis Rosell®-33 daily or placebo for the first 4 weeks of life, starting on day 1-3 of life. Infants will be followed over 36 weeks with extensive collection of meta-data and samples.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's planned enrollment of 200 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Mother:
Inclusion Criteria Infant:
Exclusion Criteria:
Participants will receive 8 x 109 CFU B. infantis Rosell®-33 per dose (single microbial active ingredient) and carrier material (maltodextrin) for 28 days from day 1-3 of life.
Dietary Supplement: B. infantis Rosell®-33
Participants will receive placebo (containing all materials besides B. infantis Rosell®-33) for 28 days from day 1-3 of life.
Dietary Supplement: Placebo
B. infantis Rosell®-33 + maltodextrin
Maltodextrin
Gut microbiome
Alpha (Shannon) and Beta (Bray Curtis and UniFrac) diversity metrics on the entire microbial communities, assessed by bacterial shotgun metagenomics of infant stool, will be compared between treatment arms
Time frame: 4 weeks of age
Markers of intestinal inflammation and microbial translocation
Concentration of markers of intestinal inflammation and microbial translocation (Lipocalin-2 (Lcn-2), sCD163, I-FABP and LBP measured by ELISA in infant plasma) will be compared cross-sectionally at each time point between groups using Mann-Whitney U tests
Time frame: 4 - 36 weeks of age
BCG vaccine respone
Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms.
Time frame: 7 weeks of age
BCG vaccine respone
Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms.
Time frame: 36 weeks of age
Longitudinal succession in gut microbiota composition, diversity and function
Longitudinal multi-omic variation will be visualized using PCoA and tSNE plots, and cross-sectional differences in multi-omic profiles will be assessed using PERMANOVAs.
Time frame: 4 - 36 weeks of age
Stool metabolome
For cross-sectional metabolite differential abundance analyses, we will use generalized linear regression (continuous dependent variable) and logistic regression (Boolean dependent variable) with an FDR correction.
Time frame: 4 weeks of age
T cell subsets frequencies
T cell subsets frequencies will be compared cross-sectionally between groups
Time frame: 4 - 36 weeks of age
Presence of total B. infantis and B. infantis Rosell®-33 in stool
qPCR will be used to assess whether B. infantis Rosell®-33 colonized.
Time frame: 4 - 36 weeks of age
Infant neurodevelopment milestones
Comprehensive neurodevelopment assessment will be conducted, e.g. using the Bayley Scales of Infant and Toddler Development, 3rd edition, or similar assessment tools, and developmental scores compared between the two arms, as well as the proportion of infants passing each developmental area assessed. Higher scores indicate better outcomes.
Time frame: 24 and 36 weeks of age
Infant growth
Infant anthropometry will be recorded at each visit to calculate infant length for age (LAZ), weight for age (WAZ) and weight for length (WLZ) Z scores and will be compared between the two arms.
Time frame: 4 - 36 weeks of age
All-cause infectious morbidity
Infectious morbidity data will be quantify and compare occurrence of infectious morbidity outcomes between randomisation arms.
Time frame: 4 - 36 weeks of age
Vaccine antibody titres
Antibody titres to early childhood vaccines will be assessed and compared by treatment arm.
Time frame: 4 - 36 weeks of age
Started Aug 2023 (actual). Primary completion is estimated for Jun 2026, 34 months after the start.
Of 497 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's planned 34 months is close to that.
Counting every sponsor, half of 500 studies reached it within 31 months; a quarter within 18 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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Acquired Immunodeficiency Syndrome →