Status:
ACTIVE_NOT_RECRUITING
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
Lead Sponsor:
Columbia University
Collaborating Sponsors:
University of Stellenbosch
University of California, Los Angeles
Conditions:
HIV
Infant Morbidity
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief Summary
Primary Objective: * To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age. * To evaluate the effects of synbiotics on infectious mor...
Detailed Description
Children who are HIV-exposed uninfected (CHEU), i.e., children born to mothers with HIV but who do not acquire HIV infection, have a higher risk of mortality, infectious morbidity, and growth deficits...
Eligibility Criteria
Inclusion
- 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)
- Women who initiated breastfeeding of their infant including:
- Women who currently exclusively breastfeed their infants, or
- Women who breastfed their infants for a period but are no longer breastfeeding, or
- Women who are currently breastfeeding their infants in addition to feeding them formula milk or solids
- 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.
Exclusion
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05282485
Start Date
June 2 2022
End Date
September 15 2026
Last Update
November 24 2025
Active Locations (1)
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1
Worcester Campus of Stellenbosch University (SU)
Stellenbosch, Western Cape, South Africa, 7599