Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides (MIGH-T MO)

This is an interventional prevention trial for HIV focused on measuring HIV, Infant Morbidity, Infant Growth, Breastmilk, Probiotic, Synbiotic, HIV-exposed Uninfected Infants, B. infantis, Human Milk Oligosaccharides, 2'-Fucosyllactose, Infant neurodevelopment Read More

Inclusion Criteria for Mothers:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Greater than 18 years of age
• For HIV-exposed uninfected children (CHEU): Mothers living with HIV documented based on medical record and with viral suppression (i.e., <400 copies/mL viral load) documented at delivery
• For HIV-unexposed uninfected children (CHUU): Mothers without HIV (document HIV-negative test result at delivery or screening)
• Only women who are currently exclusively breastfeeding and intend to breastfeed for at least another 24 weeks
• For women with HIV: Those currently on first-line standard of care antiretroviral therapy that was initiated a minimum of 12 weeks prior to delivery of the infant included in this study
• Participant has a cell phone that can be used for calls and messages
• Agreement to adhere to Lifestyle Considerations throughout study duration

Inclusion Criteria for Children:

• 3-6 weeks of age
• Delivered from a singleton pregnancy
• For children of mothers with HIV: At least one HIV diagnostic nucleic acid amplification test prior to enrollment which is negative and no positive test
• Child is well enough to have established full breastfeeding by the time of enrollment

Exclusion Criteria:

• Severe maternal or infant illness (e.g., maternal: tuberculosis, major psychiatric or neurological conditions; infant: any congenitally-acquired infections, major congenital anomalies)
• Use of immunomodulatory or immunosuppressive drugs in either mother or child prior to enrollment in the study
• For mothers with HIV: Mothers who are not currently receiving antiretroviral therapy or who are on regimens other than the currently recommended first-line standard of care in South Africa i.e., first-line dolutegravir- or efavirenz-based regimens.
• Children infected with HIV
• Mother or infant currently taking probiotics, prebiotics, or fiber supplements; or on any nutritional supplements (e.g., FM85) that impact the outcomes of interest
• Mother or infant currently taking antibiotics for more than 14 days, excluding preventative therapies
• Known allergic reactions to components of the treatment or placebo
• Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the aims of the study.