NCT05282485Completed
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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 morbidity and growth from 4 to 48 weeks of age. Secondary Objectives: * To evaluate the effects of synbiotics on growth from 4 to 72 weeks of age. * To evaluate the effects of synbiotics on infant neurodevelopment at 48 and 72 weeks of age. * To evaluate the effects of synbiotics on biological measurements while it is in place from 4 to 24 weeks of age. * To evaluate the effects of synbiotics on biological measurements from 4 to 48 weeks of age. * To evaluate the effects of synbiotics on gut microbiome and fecal short chain fatty acids from 4 to 72 weeks of age. * To investigate feasibility, acceptance, tolerability, and behavioral adherence with the intervention. * To investigate whether the synbiotics reduces infectious morbidity and improves growth in CHEU relative to CHUU. * To investigate whether infant gut microbiota composition, maturity and function, and markers of inflammation and HMOs at baseline and over time are associated with morbidity and poor growth in CHEU and CHUU.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 10 Feb 2022
- Start date
- 2 Jun 2022
- Primary completion date
- 25 Jun 2026
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT05282485
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 2 Jun 2022 to the primary completion date, 25 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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
Other illness
- Severe maternal or infant illness (e.g., maternal: tuberculosis, major psychiatric or neurological conditions; infant: any congenitally-acquired infections, major congenital anomalies)
- Children infected with HIV
- 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.
Who the study is looking for
- 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
- 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
Age in the registry: 3 weeks to 6 weeks · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Worcester Campus of Stellenbosch University (SU) Coordinator of this site? Confirm its status | Stellenbosch | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.