B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV (BifIID)

University of Cape Town (UCT)

Status: Enrolling

Conditions: Microbial Colonization; Vaccine Reaction; Infant Development; Hiv

Treatments: Dietary Supplement: B. infantis Rosell®-33; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05923333

PACTR202301748714019 (Registry Identifier)

R01HD109089 (U.S. NIH Grant/Contract)

697/2022

Details and patient eligibility

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

B. infantis Rosell®-33

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: B. infantis Rosell®-33

Placebo

Placebo Comparator group

Description:

Participants will receive placebo (containing all materials besides B. infantis Rosell®-33) for 28 days from day 1-3 of life.

Treatment:

Dietary Supplement: Placebo