RecruitingNot ApplicableNCT05923333

B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial


Sponsor

University of Cape Town

Enrollment

200 participants

Start Date

Aug 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 0 DaysMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving infants a probiotic supplement containing Bifidobacterium infantis (a beneficial gut bacteria) can improve immune development and reduce the risk of HIV infection in babies who are born to HIV-positive mothers and are breastfed. Even when a mother is on HIV medication, breastfeeding carries a small risk of transmitting HIV, and a healthy gut microbiome may help protect the baby's immune system. **You may be eligible if (mother):** - You are 18 years or older and HIV-positive - You started antiretroviral therapy (HIV medication) before the third trimester of pregnancy - You plan to exclusively breastfeed your baby for the first 6 months **You may be eligible if (baby):** - Your baby tested HIV-negative at birth - Your baby was born at full term (at least 37 weeks) with a birth weight above 2.4 kg **You may NOT be eligible if:** - Your baby has a severe illness such as sepsis at birth - Your family has known or active tuberculosis exposure - Your baby has a condition, pregnancy complication, or congenital abnormality that affects immunity - Your baby is already taking other probiotics or prebiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTB. infantis Rosell®-33

B. infantis Rosell®-33 + maltodextrin

DIETARY_SUPPLEMENTPlacebo

Maltodextrin


Locations(1)

Khayelitsha Site B Midwife Obstetric Unit

Cape Town, South Africa

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NCT05923333


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